Devices and Methods for Minimally Invasive Access to Sinuses and Treatment of Sinusitis

ABSTRACT

The present invention provides minimally invasive devices and methods for accessing the sinuses and their surrounding structures for surgery and other treatments. The anterior ethmoid and maxillary sinuses are accessed and treated under minimal anesthesia with little or no postoperative limitation of activity or adverse symptoms. Direct visual verification of the sinuses and their natural ostia is utilized. Other paranasal sinuses may be treated by this method as well. The sinuses, in particular the maxillary and anterior ethmoid, are accessed via a direct anterior to posterior axis and the natural ostia of those sinuses is directly visualized for placement of a guide-free dilator, in the desired location within the natural ostia. That access to the maxillary ostium is accomplished by the anterior transuncinate “keyhole” approach in which a hole is punched in the uncinate process with the described devices according to the described methods. The properly placed dilator is expanded to allow drainage of the inflamed sinus and then withdrawn. An analogous ethmoid bulla “keyhole” approach and subsequent dilation are used for the anterior ethmoid sinus ostia. Pharmaceutical agents may be placed at desired locations in the sinuses using the same access technique.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of application Ser. No. 12/804,398,filed Jul. 20, 2010, which claims the benefit of Provisional ApplicationNo. 61/271,500, filed on Jul. 21, 2009, the contents of which areincorporated herein by reference.

FIELD OF INVENTION

The present invention relates to minimally invasive devices, systems andmethods for accessing the sinuses of a human patient and for treatingsinusitis.

BACKGROUND OF INVENTION

There are a substantial number of people with sinus inflammatorydisease—sinusitis—that could benefit from sinus surgery. Patients withsinusitis can be grouped according to the severity of their sinusitisinto those with mild and those with severe anatomic evidence ofsinusitis. The latter category includes those patients with significantanatomic anomalies, patients previously operated on who have substantialpostoperative defects in the diseased areas, and those with significantparanasal sinus polyps. The remaining group with mild anatomic evidenceof inflammation, which makes up the largest portion of those sufferingfrom sinusitis, may nonetheless have significant and persistent symptomsdespite undergoing medical therapies. Many patients are understandablyresistant to traditional surgery, such as functional endoscopic sinussurgery (FESS), in particular if their symptoms are mild. Thus, that isthe target group for non-invasive treatments. The goal is a procedurethat is reliable, long lasting, pain free, safe, has no tissue removal,and allows an immediate return to full activities.

Development of non-invasive procedures requires an understanding of theanatomical features of the sinuses and the nasal cavity as well as anappreciation of the mucus drainage pathways. Clinically, there are fivemajor groups of sinuses in a human patient: frontal, anterior ethmoid,posterior ethmoid, maxillary, and sphenoid. The ethmoid is divided intoanterior and posterior portions to account for the clinical observationthat sinus cells anterior to the basal lamella (the lateral attachmentof the middle turbinate) have a separate mucus drainage pathway fromthose posterior to the basal lamella. The maxillary, anterior ethmoidand frontal sinuses often are affected by inflammatory disease inunison. That tendency is believed by some to be due to a shared commondrainage location; in any case, current dogma holds that inflammation inthe anterior ethmoid is an indication of inflammation in the maxillaryand frontal sinuses. For the maxillary sinus, the drainage site is theethmoid infundibulum, the very narrow space between the uncinate processmedially and the orbit laterally. For drainage of the anterior ethmoidsinuses, there are multiple sites, usually including the ethmoidinfundibulum for a small portion, and relying on the hiatus semilunarissuperior for most of the cells. That anatomic observation is notuniversally known to routine practitioners of the current art. For thefrontal sinus, the ostium usually just posteromedial to the superior endof the uncinate (or just external to the ethmoid infundibulum proper),but sometimes is lateral to the uncinate, and therefore within theinfundibulum. That slight anatomic separation coheres with the clinicalobservation that the maxillary and anterior ethmoid are very frequentlyinflamed in unison, with the frontal sinus also inflamed somewhat lessoften.

The posterior ethmoid and sphenoid sinuses are believed to haveindividual drainage sites posterior to the basal lamella. For thesphenoid, it is indisputable—the ostium can be easily seen at thesphenoid rostrum in nearly every patient if proper exposure can beobtained. For the posterior ethmoid, the putative drainage sites are notso explicit. There is some sharing of inflammatory disease by thesphenoid and posterior ethmoid sinuses. Analogous to themaxillary/anterior ethmoid/frontal system, it is believed that there isa shared pathway for the posterior ethmoid and sphenoid sinuses in thesphenoethmoid recess, the space just anterior to the sphenoid rostrum(where, as noted above, the sphenoid ostium is found) and extendinglaterally. (Stammberger, H. Functional Endoscopic Sinus Surgery. Mosby(St. Louis) 1991. See pp. 49-67.)

The vast majority of the patient group with mild anatomic sinusitis,regardless of symptom severity, has maxillary or anterior ethmoidinflammation, which also is referred to as limited maxillary andanterior ethmoid disease. If a minimally invasive treatment is to beeffective for a majority of patients, it must be effective for patientswith maxillary or anterior ethmoid inflammation.

The Maxillary Sinus

The maxillary sinus is a large air space, filling essentially the entirecheekbone in the typical patient. From the transnasal aspect, that airspace lies just lateral to the entire lower half of the lateral wall ofthe nose. From the oral/sublabial aspect, it lies just superior to thetooth roots from the canine to the last molar and extends to the orbit.The maxillary sinus is relatively large and most of it is relatively farfrom the eye, which is the most important structure in that area.Traditional access to the maxillary sinus involved either forcing atrocar through the low lateral nasal wall or sublabially through theanterior wall of the sinus just lateral to the canine root or both,followed by the enlargement of the resulting hole via removal of bone todrain the sinus and remove any diseased tissue. Those approaches weredeveloped to best avoid damaging the eye, yielding a suitable surgicalmargin of error for that purpose. At the end of the procedure, onesought to preserve the intranasal hole in the belief that the sinuswould continue to drain through it for the rest of the patient's life,an assumption later realized to be incorrect.

A seminal development in sinus surgery was Messerklinger's work in the1960's (and applied clinically in the 1980's) on the physiology of sinusclearance of mucus, and its rather rigid connection to sinusmicroanatomy. (Messerklinger, W., multiple references quoted inStammberger, ibid., pp. 27-28.) Among other observations,Messerklinger's work involved placing traceable, visible granules intothe maxillary sinuses. Using a high resolution endoscope, he observedthat the granules would migrate along the lining in a very specificpath, exiting the maxillary sinus through an ostium near the anteriorsuperior extreme of the sinus, lateral to the uncinate process, andfollowing an explicit and narrow stream just above the inferiorattachment of the uncinate to the lateral wall, before exiting thatnarrow space posteriorly. Of crucial interest, that pathway waspreserved independent of any other, even larger, holes that might exist,naturally or surgically, in the medial wall of the sinus. In effect, thecilia always push sinus mucus in the direction of the so-called naturalostium, whether or not other ostia exist or are created. Thatobservation suggested that the previously-held belief in the benefit ofsurgically-created sinus ostia was misplaced. The new paradigm was tobecome surgical enlargement of the natural ostium explicitly, finallygaining wide adoption in the early 1990's with utilization of functionalendoscopic sinus surgery (FESS), particularly among new trainees andprofessors. That strategy subsequently has been validated clinically.Placement of ostia elsewhere was too often found to be useless orinjurious and, crucially, those problems could be reliably correctedonly by addressing the natural ostium in an appropriate way. Thatprinciple continues to be important, beneficially if honored,detrimentally if neglected.

In state-of-the-art endoscopic maxillary sinus surgery today, theuncinate process first is removed from its posterior margin back to itsanterior maxillary attachment, revealing the (often small) naturalostium just posterior to the anterior maxillary attachment. The naturalostium is assessed. If deemed too small to effectively permit long-termdrainage from the sinus (an arbitrary decision), it is enlargedposteriorly. In approximately one-third of patients, there is anaturally occurring accessory ostium posterior to the natural ostium. Inthose patients, the surgeon enlarges the natural ostium to broadlyconnect with and encompass the accessory ostium to avoid having mucusrecirculate; i.e., to prevent mucus that is exiting the sinus via theaugmented natural ostium from reentering via the accessory ostium. It isnot clear how often that pathway is utilized for recirculation, if ever.A problem results, however, if a surgeon creates a new ostium posteriorto the natural ostium, which often does cause recirculation, or if asurgeon enlarges an accessory ostium thinking it to be the natural one,which will not achieve the objective and might, as discussed above,cause recirculation. If those errors occur, they usually can becorrected by finding the natural ostium and connecting it with theaccessory ostium to create a single large ostium.

The minimally invasive balloon sinuplasty surgical method forapplication to the maxillary sinus, as exemplified by the transnasalapproach of U.S. Pat. No. 7,500,971, which is incorporated herein byreference in its entirety, involves placing a curved, tubular guide intothe posterior slit-like opening of the infundibulum, between theposterior margin of the uncinate medially and the orbital walllaterally. A guide wire is then fed through the lumen of the tube andinto the infundibulum. The wire is gently manipulated until it, by trialand error, drops into the ostium. The tip can be verified to be in thesinus by X-ray fluoroscopy or more commonly by light from the wire tipseen to transilluminate the cheek. See, e.g., U.S. Pat. No. 7,559,925.Both X-ray fluoroscopy and transillumination are cumbersome to a degree,fluoroscopy especially so as it requires large machines that are notnormally present at sinus surgery and get in the way of easy,interruption-free operating. The wire transillumination method is moreconvenient, but requires the surgeon to juggle instruments in his/herhands and creates tangles on an operative field already wound with avariety of suction hoses and cords. Fluoroscopy and transilluminationcan assist the surgeon in determining if the instrument is in the sinus,but do not indicate whether the instrument is in the natural ostium.Thus, they are not substitutes for direct visualization. The ballooncatheter is passed through the lumen of the tubular guide over the wireuntil it is believed to be spanning the ostium at which point it isexpanded, putatively stretching the ostium and spreading the spacebetween the orbit and uncinate by stretching the uncinate medially. Asnoted above, that action may instead result in dilation of an accessoryostium.

Another minimally invasive sinuplasty method, as exemplified by thecanine fossa approach of U.S. Pat. No. 7,520,876, which is incorporatedherein by reference in its entirety, utilizes the older sublabialapproach to the maxillary sinus (described above), which requirespuncturing the bone of the alveolus just above the tooth roots in thecanine fossa region. The anterior wall of the maxillary sinus ispunctured a bit lateral to the canine root. A miniature endoscope ispassed coaxially through a tubular guide and advanced into the sinus andthe natural ostium is directly visualized from this lateral aspect. Theballoon catheter is passed into the ostium by manipulation of the guideaccording to what is visualized with the endoscope and the balloon isexpanded.

Both the transnasal and canine fossa approaches have disadvantages. Inthe transnasal approach, the advance to the infundibulum is awkward.Surgical instrumentation—including the guides, balloon catheter,endoscope and guide wire—is introduced into the nose from anterior toposterior, but the infundibulum is entered posteriorly and the wireadvanced anteriorly from that point. Those two maneuvers necessitate a180 degree turn of the guide, guide wire and balloon catheter that isdifficult to execute atraumatically in the tight spaces involved.

Another substantial problem with the transnasal approach is that themethod is performed blindly because the surgeon's view of the naturalostium and any intervening accessory ostia is blocked by the more medialuncinate. The instrumentation is rounded and made flexible to avoidinadvertent introduction into the eye. However, that does not preventinadvertent introduction into and cannulation of an accessory ostium,rather than the natural ostium, caused by the surgeon's inability to seethe position of the instrument. In fact, in the significant number ofcases that an accessory ostium is present (estimated at about one thirdof all patients), the accessory ostium is encountered first by the guidewire, as it is more posteriorly placed, and is probably more likely tobe dilated than the natural ostium. In such cases, the surgeonmistakenly enlarges the accessory ostium rather than the natural ostium.As discussed above, that is not helpful and often harmful. Protectingagainst that eventuality is difficult. It is common, therefore, forsurgeons to resort to a “hybrid” invasive/non-invasive procedure inwhich the lower uncinate is surgically removed to visualize the naturalostium in the usual fashion. Performed appropriately by a competentsurgeon, the “hybrid” approach solves the problem, but necessitatesreverting to an essentially standard approach that is more thanminimally invasive. Using a balloon to dilate the now visible naturalostium is of questionable benefit compared to the standard surgicalapproach of trimming the posterior margin of the ostium—likely a merevictory of style over substance. Surgeons that would prefer a minimallyinvasive method will often revert to the unsatisfactory “hybrid”procedure because of frustration with the awkward approach to thenatural ostium or because of concern that they will inadvertently andunknowingly dilate the wrong (accessory) ostium.

The canine fossa approach offers the advantage that the surgeon accessesthe maxillary sinus and views the ostia from inside the sinus, fromwhich they can be seen unobstructed. If more than one ostium exists, thenatural ostium will be the anterior one, so verification of the naturalostium and avoidance of the accessory ostium is possible. The route alsois direct. It does not require a 180 degree turn. Proponents of thecanine fossa approach of U.S. Pat. No. 7,520,876 further represent thatthe balloon dilation succeeds in also enlarging the ethmoid infundibulumin that it stretches the uncinate medially, and it certainly seems thatit does so. They claim that balloon dilation of the ethmoidinfundibulum, in addition to treating the maxillary sinus, results intreating the primary ethmoid drainage, which apparently is believed tobe located in the ethmoid infundibulum. The anatomic evidence, however,is overwhelmingly against that possibility.

Nonetheless, the problems with the canine fossa approach aresubstantial. It requires a separate incision and access for a trocarunder the lip. Thus, it is not easily and naturally combined withintranasal procedures. Moreover, it is more difficult or impossible toaccess the ethmoid, frontal, and sphenoid sinuses from the canine fossaaccess site. Access to the anterior ethmoid is possible, but cumbersome.Access to the frontal sinus is quite difficult, and access to theposterior ethmoid and sphenoid is virtually impossible. Surgeons mustutilize another “hybrid” invasive/non-invasive procedure for thosesinuses that require a second incision site and a cumbersome combinationof nasal and oral procedures. The primary incision required by thecanine fossa approach might be undesirable to patients seeking lessrather than more surgery. Surgeons likewise might hesitate to embraceit.

The canine fossa procedure also utilizes a miniature endoscope. Theimage quality of the miniature endoscopes that are commerciallyavailable are suboptimal due to the very fine fiberoptic threadtransmitting the image. The endoscope is understandably fragile with ashort (25 procedures) life and therefore carries a rather high cost peruse.

In sum, there is a need for a minimally invasive method to access anddilate the natural ostium of the maxillary sinus, preferably viatransnasal access, without commonly resorting to traditional resectionas a “hybrid” rescue during the procedure. Access to the natural ostiumshould be direct and not awkward so as to not frustrate the surgeon andto avoid trauma, should be verifiable, and should be easy to combinewith minimally invasive approaches to the other sinuses.

The Anterior Ethmoid

The drainage pathways of the anterior ethmoid sinus are less explicitlydefined than in the maxillary sinus. The ethmoid sinuses, anterior andposterior, are often referred to as a labyrinth. Unlike the maxillarysinus, the ethmoid is partitioned into many small contiguous cells, withthe anterior cells draining anterior to the basal lamella (andcontaining more and smaller chambers) and the posterior cells drainingposterior to the basal lamella (and containing one to three or so largerchambers). The labyrinth occupies roughly the upper half of the nose, isbounded superiorly by the rather thin skull base (and brain beyond), andlaterally by the orbit. Landmarks are less explicit and more variablethan those in the maxillary sinus area. Consequently, serious injuriesto the eye and brain during sinus surgery can occur in approaches to theethmoid.

Traditional invasive ethmoid surgery utilized an incision between theeye and the nose and a puncture of the medial wall of the orbit toaccess the ethmoid. The surgeon penetrated the ethmoid sinuses below thefrontoethmoid suture line (which lies roughly at the equator of theorbit at the level of the corner of the eye) to avoid the brain whileremoving pieces of ethmoid bone and nasal lining. That approach wasrendered obsolete for most cases in the 1990's with the maturation ofendoscopic sinus surgery.

In the current standard of endoscopic surgery of the anterior ethmoid,the largest and most prominent cell of the anterior ethmoid, the ethmoidbulla, is opened and its walls and those of adjacent cells are removeduntil opened “enough” (an arbitrary designation). Experience has shownthat the opening of the ethmoid bulla and those adjacent cells fixesmild sinusitis satisfactorily in most cases.

Minimally invasive methods for ethmoid surgery have not progressed asfar as those methods for maxillary surgery. This deficiency is likelydue to the significant anatomic variation of the anterior ethmoidanatomy and confusion within the field as to the location of its mucusoutlets. The accepted minimally invasive paradigm would require that oneidentify and open those outlets, an objective only partiallyaccomplished (usually without specific identification) in the routineart by resecting most of the septations of the anterior ethmoid, and notyet addressed in the prior balloon-dilation art.

One relatively new method in the minimally invasive realm avoids theanatomic variation problem entirely by circumventing the paradigm ofdilating natural ostia. Instead, in this method, the ethmoid bulla isengaged with a trocar that is pushed through its anterior and posteriorwalls, into the posterior ethmoid. A reservoir is then passed into thetunnel to rest in the anterior and posterior ethmoid. The reservoircontains steroid that elutes into the sinus over days-to-weeks,decreasing inflammation.

It is reasonable to speculate that application of targetedpharmacotherapeutic agents, as in the above method, will be a helpfuladjunct to the treatment of sinusitis. In the current routine sinus art,topical steroid spray is a mainstay of treatment, and topicalantibiotics and antifungals are occasionally used to treat selectpatients. The benefits from these topical agents, however, have beenlimited. There is reason to suspect that the limitation is due to aninability to direct the agents to the diseased areas of intact sinusesin sufficient concentrations to be effective, rather than to some morefundamental shortcoming. In an analogous situation, acute and chronicinfections and inflammation of the ear canal skin are much more rapidlyand effectively treated with topical agents than with oral ones. Topicalmedications probably result in local pharmaceutical concentrations thatare several orders of magnitude greater than those safely achievable inoral administration. Obviously, the ear canal is more easily targetedwith repeated administration of concentrated therapeutic agents than themore hidden recesses of the paranasal sinuses.

The aforementioned placement of a pharmaceutical-eluting implantabledevice seeks to surmount that largely anatomic challenge, and hasachieved some promising early results. There are certainly somedrawbacks to this method, however. The placement of the device altersanterior ethmoid anatomy without explicit attention to the naturaldrainage pathways thereof, possibly, although not necessarily,compromising mucus clearance in the long-term. Taken together, the costof the device and the nature of its placement do not lend themselves torepeated use in an office setting; rather, they are more suited to asingle treatment or very occasional treatments in a surgical setting. Asmany patients have some degree of ongoing medical sinus disease, this isa significant drawback. Ideally, one would prefer that targetedpharmacotherapy be a viable alternative to oral therapy for manypatients, necessitating a more convenient and inexpensive option.Lastly, the method by which the trocar is directed into the sinuses isof some concern. One would prefer, if possible, a more precise and lesstraumatic means of accessing the ethmoid sinuses. A reliable means totreat the maxillary sinus with targeted pharmacotherapy would also bedesirable, an option lacking in the prior art. This gap in currenttreatment options is largely because of the presence of the uncinate,which prevents direct atraumatic access to the maxillary sinus,frustrating the guide-based system currently used.

In sum, there is a need for a minimally invasive method for accessingand treating the anterior ethmoid that augments flow through naturaldrainage pathways of the anterior ethmoid. There further is a need for aminimally invasive means to introduce targeted pharmacotherapeuticagents to the maxillary and anterior ethmoid sinuses (as well as others)in a more cost-effective and atraumatic manner than in the current art.

SUMMARY OF INVENTION

The present invention provides devices and methods to refine theexisting minimally invasive methods for accessing the sinuses and theirsurrounding structures for surgery and other treatments. In preferredembodiments of the present invention, the anterior ethmoid and maxillarysinuses are accessed in a minimally invasive manner for treating mildinflammatory disease of those spaces, enabling surgical treatment formild-to-moderate sinusitis to be performed under minimal anesthesia inan office setting, if desired, and with little or no postoperativelimitation of activity or adverse symptoms. To facilitate broadapplication, the devices of the present invention have a form andmaneuverability similar to those used routinely by practitioners ofendoscopic sinus surgery so that the methods of the present inventioncan be easily taught, learned, and executed.

In one aspect of the present invention, a method of treating a congestedmaxillary sinus via a minimally invasive intranasal approach includesmaking a perforation (“keyhole”) in the uncinate process, inserting aguide-free dilator through the keyhole perforation and dilating thenatural ostium of the maxillary sinus or the ethmoid infundibulum.

In another aspect of the present invention, a method of treating acongested anterior ethmoid sinus pathway via a minimally invasiveintranasal approach includes dilating the hiatus semilunaris superior,making a perforation (“keyhole”) in the thin wall surrounding theethmoid bulla, inserting a guide-free catheter through the keyholeperforation and dilating the ethmoid bulla ostium.

In another aspect of the present invention, a method of opening aconstricted ethmoid sinus passageway includes introducing a probe intothe nose, engaging the ethmoid bulla ostium, stretching the ethmoidbulla ostium, introducing a guide-free dilator into the hiatussemilunaris superior and dilating the hiatus semilunaris superior.

In yet another aspect of the present invention, a method of opening aconstricted ethmoid sinus passageway includes introducing a probe intothe nose, engaging the ethmoid bulla ostium, stretching the ethmoidbulla ostium, introducing a guide-free dilator into the hiatussemilunaris superior, dilating the hiatus semilunaris superior, making aperforation (“keyhole”) in the thin wall surrounding the ethmoid bulla,inserting a guide-free catheter through the keyhole perforation anddilating the ethmoid bulla ostium.

In yet another aspect of the present invention, a method of introducingan active agent into a constricted maxillary sinus includes making aperforation (“keyhole”) in the uncinate process, inserting a drugdelivery device containing the active agent through the keyhole, andeluting the drug in the maxillary sinus.

In yet another aspect of the present invention, a method of introducingan active agent into a constricted anterior ethmoid sinus, particularlythe ethmoid bulla, includes making a perforation (“keyhole”) in the wallof the ethmoid bulla, inserting a drug delivery device containing theactive agent through the keyhole, and eluting the drug in the sinus.

In still another aspect of the present invention, a method of retractingthe middle turbinate includes introducing a middle turbinate retractorinto the axilla of the middle meatus and expanding the middle turbinateretractor to retract the middle turbinate.

Another aspect of the present invention includes a middle turbinateretractor comprising two rigid parallel platforms composed of metal orplastic and a metal or plastic spring situated between the rigidplatforms and a pair of forceps on the outer surfaces of the parallelplatform that allow for expansion and compression of the spring.

Another aspect of the present invention includes a middle turbinateretractor comprising two parallel arms that are capable of beingexpanded or compressed with respect to each other, said arms crossingeach other, thereby forming an upper portion and a lower portion, a pairof expansion receptacles at the lower portion of each arm, wherebysqueezing of said expansion receptacles results in expansion of theparallel arms and a ratchet arm connected at the upper portion of eachparallel arm capable of holding the parallel arms in place.

Another aspect of the present invention includes a hole punch capable ofmaking a perforation in the uncinate process comprising a shaft, astationary platform mounted on the shaft, a blade attached to one end ofthe stationary platform, a mobile tapered flange containing a receptaclepivotally connected to the stationary platform, and a means of bringingthe blade of the stationary platform and the receptacle of the mobiletapered flange together, thereby generating a perforation in theuncinate process.

Yet another aspect of the present invention includes a guide-freedilator comprising a rigid shaft with a bottom portion and a topportion, a rigid handle mounted at the bottom portion of the rigidshaft, and a dilator segment mounted at the top portion of the rigidshaft. The dilator segment is comprised of a semiridgid shaft and amounting balloon. In one embodiment, top portion of the rigid shaft isangled in the range of from about 30 degrees to about 60 degrees.

Still another aspect of the present invention includes a medial ethmoidprobe comprising a handle having a top portion and a bottom portion anda shaft having a proximal segment and a distal segment, said proximalsegment comprising a rigid material mounted on the top portion and thebottom portion of the handle and said distal segment comprising asemirigid material with a curved tip to engage an ostium in the ethmoidbulla. Preferably, the distal segment of the shaft curves to an angleranging from about 30 degrees to about 60 degrees.

Still another aspect of the present invention includes a probe capableof making a perforation in the wall of the ethmoid bulla comprising ahandle having a top portion and a bottom portion, an upper shaft mountedon the top portion of said handle, a lower shaft mounted on the bottomportion of said handle, and a perforator tip with a stop collar, saidperforator tip mounted on the upper shaft.

Yet another aspect of the present invention includes a drug insertiondevice comprising a rigid shaft containing a lumen, said rigid shaftangled distally at an angle between about 55 degrees and about 60degrees, a piston coaxial with and guided by said lumen of said rigidshaft, a receptacle for holding a drug or drug delivery device, saidreceptacle mounted at the distal end of the rigid shaft, and a means formoving the piston through the lumen of the rigid shaft to thereceptacle, causing release of the drug or drug delivery device.

Still another aspect of the present invention includes a device forcontrolled delivery of a drug into a sinus, comprising a drug containingmatrix and a degradable framework having a spine and a series ofcoplanar ribs protruding radially from the spine, the tips of the ribsprotruding past the outer surface of the drug containing matrix, whereinthe drug containing matrix degrades at a rate faster than the degradableframework.

Still another aspect of the present invention includes a device forcontrolled delivery of a drug into a sinus comprising a drug containingmatrix and a degradable framework having a spine and an umbrella of ribsattached to the spine, said umbrella is on the outside surface of thedrug containing matrix, wherein the umbrella expands upon insertion intothe sinus and wherein the drug containing matrix degrades at a ratefaster than the degradable framework.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A-1C illustrate a sagittal view of the lateral nasal wall withvarious anatomical features thereof.

FIGS. 2A-2B illustrate one embodiment according to the present inventionof an anterior/superior middle turbinate retractor in compressed andexpanded forms, respectively.

FIGS. 3A-D illustrate one embodiment of the present invention showingmiddle turbinate retraction by expansion of an anterior/superior middleturbinate retractor.

FIGS. 4A-4B illustrate one embodiment according to the present inventionof a posterior/inferior middle turbinate retractor in compressed andexpanded forms, respectively

FIGS. 5A-5B illustrate an alternative embodiment according to thepresent invention of a posterior/inferior middle turbinate retractor incompressed and expanded forms, respectively

FIGS. 6A-6B illustrate an alternative embodiment according to thepresent invention of a posterior/inferior middle turbinate retractor incompressed and expanded forms, respectively

FIGS. 7A-7B illustrate one embodiment of the present invention showingmiddle turbinate retraction by expansion of a posterior/inferiorturbinate retractor.

FIG. 7C illustrates a sinus in which the middle turbinate is retractedusing a posterior/inferior turbinate retractor of the present invention.

FIG. 7D illustrates a sinus in which the middle turbinate is notretracted.

FIG. 8A illustrates the anatomical structures observed during a typicalanteroinfermedial-to-posterosuperolateral view during nasal endoscopy(i.e., endoscopic view).

FIG. 8B illustrates a medial-to-lateral sagittal view of the relevantstructures of the middle meatus.

FIG. 8C illustrates a transverse view from superior-to-inferior of therelevant structures of the middle meatus.

FIG. 9A illustrates a backbiting hole punch according to one embodimentof the present invention.

FIGS. 9B-9D illustrate a side view, a top view and an end-on view,respectively, of the mobile tapered flange of the backbiting hole punchof the present invention.

FIGS. 9E-9G illustrate a side view, a top view and an end-on view,respectively, of the stationary platform of the backbiting hole punch ofthe present invention.

FIG. 9H illustrates a view of the handles of the backbiting hole punchof the present invention.

FIGS. 91-93 illustrate an alternative stationary platform of thebackbiting hole punch of the present invention.

FIGS. 10A-10C illustrates three views (endoscopic, sagittal, transverse)of the intended site of the uncinate process “keyhole” formed usinginstruments and methods of the present invention.

FIGS. 11A-11C illustrate three views (endoscopic, sagittal, transverse)of initial placement of the backbiting hole punch into the posterioropening of the ethmoid infundibulum and the levering of the uncinate, inaccordance with one aspect of the present invention.

FIGS. 12A-12C illustrate three views (endoscopic, sagittal, transverse)of final placement of the backbiting hole punch into the posterioropening of the ethmoid infundibulum and the levering of the uncinate, inaccordance with one aspect of the present invention.

FIGS. 13A-13C illustrate three views (endoscopic, sagittal, transverse)of creating a keyhole in the uncinate process, in accordance with oneaspect of the present invention.

FIGS. 14A-14C illustrate three views (endoscopic, sagittal, transverse)of the keyhole created in the uncinate process, in accordance with oneaspect of the present invention.

FIG. 15A illustrates one embodiment of a guide-free dilator of thepresent invention.

FIG. 15B illustrates an alternative embodiment of the guide-free dilatorof the present invention.

FIG. 15C illustrates a view of one embodiment of the dilator of theguide-free dilator of the present invention.

FIG. 15D illustrates a view of an alternative embodiment of the dilatorof the guide-free dilator of the present invention.

FIGS. 16A-16C illustrate three views (endoscopic, sagittal, transverse)of advancement of a guide-free dilator of the present invention throughthe transuncinate keyhole and dilation of the ethmoid infundibulum, inaccordance with one aspect of the present invention.

FIGS. 17A-17C illustrate three views (endoscopic, sagittal, transverse)of dilation of the natural ostium of the maxillary sinus using aguide-free dilator, in accordance with one aspect of the presentinvention.

FIGS. 18A-18C illustrate three views (endoscopic, sagittal, transverse)of dilation of the transuncinate keyhole using a guide-free dilator, inaccordance with one aspect of the present invention.

FIGS. 19A-19C illustrates attachment of the natural ostium of themaxillary sinus with an accessory ostium, according to one aspect of thepresent invention.

FIG. 20 illustrates a view from medial to lateral of the structureslateral to the middle turbinate with the turbinate removed.

FIG. 21A illustrates the typicalanteroinferomedial-to-posterosuperolateral view obtained during nasalendoscopy,

FIG. 21B illustrates a medial-to-lateral sagittal view of the relevantstructures of the middle meatus.

FIG. 21C illustrates a transverse view from superior-to-inferior of therelevant structures of the middle meatus.

FIGS. 22A-22C illustrate three views (endoscopic, sagittal, traverse) oflocating the ethmoid bulla ostium using an ethmoid probe of the presentinvention.

FIGS. 23A-23C illustrate three views (endoscopic, sagittal, traverse) ofexpansion of the ethmoid bulla ostium using an ethmoid probe of thepresent invention.

FIGS. 24A-24C illustrate three views (endoscopic, sagittal, traverse) ofdilating the hiatus semilunaris superior using a guide-free dilator, inaccordance with one aspect of the present invention.

FIGS. 25A-25C illustrate three views (endoscopic, sagittal, traverse) ofdilating the ethmoid bulla ostium using a guide-free dilator, inaccordance with one aspect of the present invention.

FIG. 26A illustrates an ethmoid probe of the present invention.

FIG. 26B illustrates the axis of approach of the ethmoid probe of thepresent invention.

FIG. 26C illustrates a detail the curved tip of the ethmoid probe of thepresent invention.

FIGS. 27A-27C illustrate three views (endoscopic, sagittal, traverse) ofthe desired site of the ‘keyhole’ in the wall of the ethmoid bulla,using the anterior keyhole approach of the present invention.

FIGS. 28A-28C illustrate three views (endoscopic, sagittal, traverse) ofusing the ethmoid keyhole probe of the present invention to make aperforation in the wall of the ethmoid bulla.

FIGS. 29A-29C illustrate three views (endoscopic, sagittal, traverse) ofdilating the perforation in the wall of the ethmoid bulla using theethmoid keyhole probe of the present invention.

FIGS. 30A-30C illustrate three views (endoscopic, sagittal, traverse) ofremoving the ethmoid keyhole probe of the present invention followingdilation.

FIGS. 31A-31C illustrate three views (endoscopic, sagittal, traverse) ofenlarging the perforation in the wall of the ethmoid bulla using aguide-free dilator, in accordance with one aspect of the presentinvention.

FIGS. 32A-32C illustrate three views (endoscopic, sagittal, traverse) ofenlarging the perforation in the wall of the ethmoid bulla using asphenoid punch, in accordance with one aspect of the present invention.

FIGS. 33A-33C illustrate three views (endoscopic, sagittal, traverse) ofenlarging the ethmoid bulla ostium using a guide-free dilator, inaccordance with one aspect of the present invention.

FIG. 34 illustrates an ethmoid keyhole probe of the present invention.

FIGS. 35A-B illustrate alternative embodiments of a guide-free dilatorof the present invention.

FIG. 36A illustrates an endoscopic view (70 degrees) of introducing anendoscope into the region surrounding the frontal sinus, in accordancewith one aspect of the present invention.

FIG. 36B illustrates a sagittal view of introducing an endoscope intothe region surrounding the frontal sinus, in accordance with one aspectof the present invention.

FIG. 37A illustrates an endoscopic view (70 degrees) of advancement of aguide-free dilator of the present invention into the frontal ostiumfollowed by dilation, in accordance with one aspect of the presentinvention.

FIG. 37B illustrates a sagittal view of advancement of a guide-freedilator of the present invention into the frontal ostium followed bydilation, in accordance with one aspect of the present invention.

FIGS. 38A-C illustrate an embodiment of a guide-free drug placementdevice of the present invention.

FIGS. 39A-C illustrate an alternative embodiment of a guide-free drugplacement device of the present invention.

FIGS. 40A-40C illustrate three views (endoscopic, sagittal, transverse)of placement of a pharmaceutical agent in the maxillary sinus, inaccordance with one aspect of the present invention.

FIGS. 41A-41C illustrate three views (endoscopic, sagittal, transverse)of placement of a pharmaceutical agent in the anterior ethmoid sinus, inaccordance with one aspect of the present invention.

FIGS. 42A-B illustrate a front view and cross-sectional view,respectively, of a bioerodible drug delivery device of the presentinvention.

FIGS. 43A-B illustrate a front view and cross-sectional view,respectively, of an umbrella-type bioerodible drug delivery device ofthe present invention prior to delivery into the sinus.

FIGS. 43C-D illustrate a front view and cross-sectional view,respectively, of an umbrella-type bioerodible drug delivery device ofthe present invention after delivery into the sinus.

FIGS. 44A-B illustrate a front view and cross-sectional view,respectively, of an alternative embodiment of a bioerodible drugdelivery device of the present invention.

DETAILED DESCRIPTION OF INVENTION

The following sections describe exemplary embodiments of the presentinvention. It will be apparent to those skilled in the art that thedescribed embodiments of the present invention provided herein areillustrative only and not limiting, having been presented by way ofexample only. All features disclosed in this description may be replacedby alternative features serving the same or similar purpose, unlessexpressly stated otherwise. Therefore, numerous other embodiments ormodifications thereof are contemplated as falling within the scope ofthe present invention as defined herein and equivalents thereto.

Throughout the description, if items are described as having, including,or comprising one or more specific components, or if processes andmethods are described as having, including, or comprising one or morespecific steps, it is contemplated that, additionally, there are itemsof the present invention that consist essentially of, or consist of, theone or more recited components, and that there are processes and methodsaccording to the present invention that consist essentially of, orconsist of, the one or more recited processing steps.

It should be understood that the order of steps or order for performingcertain actions is immaterial, as long as the invention remainsoperable. Moreover, two or more steps or actions may be conductedsimultaneously. Scale-up or scale-down of systems, processes, units,and/or methods disclosed herein may be performed by those of skill inthe relevant art.

The invention provides novel devices and methods for accessing thesinuses and their surrounding structures for surgery and othertreatments. The devices and methods are useful in the treatment of mildor severe sinusitis. The devices of the present invention have a formand maneuverability that will be suitable for routine use by currentpractitioners of endoscopic sinus surgery so that the methods of thepresent invention can be easily taught, learned, and executed. Themethods of the present inventions are substantially non-invasive orminimally invasive and are pain free, safe and long lasting. The methodsof the present invention can be performed under minimal anesthesia in anoffice setting, if desired, and with little or no postoperativelimitation of activity or adverse symptoms.

In the figures described below, various anatomical structures of thesinuses and nasal cavity are displayed. The following reference lettersare used in the diagrams to show these anatomical features.

-   AAUP anterior attachment of the uncinate process-   AN agger nasi cell-   AO accessory ostium-   BL basal lamella-   EB ethmoid bulla-   EBO ethmoid bulla ostium-   EI ethmoid infundibulum-   FS frontal sinus-   FO frontal ostium-   HSS hiatus semilunaris superior-   IAUP inferior attachment of the uncinate process-   IT inferior turbinate-   KH keyhole-   LF lacrimal fossa-   LP lacrimal prominence-   LW lateral wall-   MS maxillary sinus-   MSA maxillary sinus antrum-   MT middle turbinate-   MTB middle turbinate body-   N nostril-   NOMS natural ostium of the maxillary sinus-   OW orbital wall-   OZ ostial zone-   PAUP posterior attachment of the uncinate process-   PE posterior ethmoid-   PRMT posterior root of middle turbinate-   SRMT superior root of middle turbinate-   SS sphenoid sinus-   UKP uncinate keyhole punch-   UP uncinate process-   VRMT vertical root of the middle turbinate

A brief initial overview of some of the relevant anatomy is in order. InFIG. 1A, the right side of the nose is represented in amedial-to-lateral sagittal view. The diagram depicts the nostril (N),the interior turbinate (IT), the middle turbinate (MT), the frontalsinus (FS) and the sphenoid sinus (SS). The crucial structures to bemanipulated in the method of the present invention lie lateral to themiddle turbinate (MT). If the middle turbinate is reflected superiorlyfor clarity (FIG. 1B), we see the largest cell of the ethmoid complex,the ethmoid bulla (EB) and, anterior-inferior to it, the uncinateprocess (UP). Manipulation of the ethmoid bulla (EB) will be outlined inthe description of the method below. The opening of the maxillary sinus,its natural maxillary ostium (NOMS), lies just lateral to theanterior-inferior attachment of the uncinate and can be seen if weremove the uncinate, again for clarity (FIG. 1C). It should be apparentfrom this discussion that both the middle turbinate (MT) and uncinateprocess (UP) comprise physical and visual barriers to manipulations ofthe ethmoid bulla (EB) and natural ostium of the maxillary sinus (NOMS).The method and devices of the present invention are designedaccordingly, to address and remedy these challenges.

Retraction of the Middle Turbinate

As depicted in FIG. 1A and FIG. 1B, the middle turbinate (MT) obstructsthe surgeon from clearly viewing the uncinate process (UP) and theethmoid bulla (EB). In the non-invasive procedures described below, itmay be advantageous to first temporarily retract the middle turbinatefrom the procedural area and then restore it once the procedure iscomplete. To this end, I have developed turbinate retractors that assistthe surgeon in visualizing the relevant anatomy around the obstructedsinus cavities. One embodiment of turbinate retractors in accordancewith the present invention is displayed in FIGS. 2A-2B. FIGS. 2A and 2Bdepict an anterior/superior middle turbinate retractor (1) in compressedand expanded states, respectively. The anterior/superior middleturbinate retractor (1) is compressed (FIG. 2A) for introduction intothe narrow space between the middle turbinate and lateral nasal wall inwhich it is allowed to passively expand (FIG. 2B) for gentle retraction.The retractor consists of a thin rigid metal or plastic frame (2)approximating a V-shape. An intervening pliable metal or plastic spring(3) enables compression and expansion upon squeezing and releasing theforceps receptacles (4). Pads (5) are placed at the contact surfaces ofthe lateral nasal wall and middle turbinate. These consist of a slightlycompressible substance (e.g., foam rubber) surfaced with a smooth thinnonadherent, nonabrasive film to avoid trauma to the nasal lining.Preferably, the device should compress to a width of less than 3 mm andshould be able to expand to a width that need not markedly exceed 10 mm.

FIGS. 3A-3D show application of the use of the anterior/superior middleturbinate retractor (1) of the present invention. In the intact andunoperated nose, the middle turbinate (MT) obstructs the view of thestructures practitioners wish to manipulate from the routine endoscopicvantage point (FIGS. 3A and 3B). Placement of the anterior/superiorretractor (1) into the axilla of the middle meatus (FIG. 3C) and itssubsequent expansion (FIG. 3D) reveals those structures and maintainsthe view throughout the procedure without repeated manipulation of themiddle turbinate (MT), which is often otherwise required.

The middle turbinate (MT) may also be retracted medially by anotherdevice of the present invention depicted in FIGS. 4A-4B. FIGS. 4A and 4Bdepict an embodiment of a posterior/inferior middle turbinate retractor(6) in compressed and expanded form, respectively. Theposterior/inferior middle turbinate retractor (6) is wedged between thelateral wall of the nose and the middle turbinate just posterior andinferior to the posterior root of the uncinate process (refer to FIGS.7A-7F). The posterior/inferior middle turbinate retractor (6) functionsvia a passive spring compression-expansion mechanism, analogous to thatdescribed above for the anterior-superior retractor shown in FIGS.2A-2B. The posterior-inferior middle turbinate retractor consists of tworigid metal or plastic platforms (7) with an intervening metal orplastic spring (8). It may be preferable to have the spring encased in athin plastic sleeve (9) to aid in spring alignment and to avoidtangling. The device is manipulated via the forceps receptacles (10),similar to the anterior/superior middle turbinate retractor. Similarpadding also is present here (11) with a curvature (12) incorporated toaccommodate the anatomy near the middle turbinate (MT).

Another embodiment of the posterior/inferior middle turbinate retractorof the present invention is depicted in FIGS. 5A and 5B. FIGS. 5A and 5Bdepict an embodiment of a posterior/inferior middle turbinate retractor(13) in compressed and expanded form, respectively. In this embodiment,posterior/inferior middle turbinate retractor (13) expands by aratcheting mechanism and passively contracts upon release. The device(13) consists of two rigid metal or plastic arms. The first plastic arm(14) comes in contact with the lateral wall of the nose and the secondplastic arm (15) abuts the middle turbinate. The arms are activelyexpanded by squeezing the expansion receptacles (16 and 17) together.The arms are held in expansion by the ratchet arm (18) at the desiredwidth and released by squeezing the release receptacle (19) toward theexpansion receptacle (17). Pads (20) also may be present on this device.Dimensions of the arms (14) should be similar to those describedpreviously for the anterior/superior middle turbinate retractor.

Another embodiment of the posterior/inferior middle turbinate retractorof the present invention is depicted in FIGS. 6A and 6B. FIGS. 6A and 6Bdepict an embodiment of a posterior/inferior middle turbinate retractor(21) in compressed and expanded form, respectively. The retractorconsists of a thin rigid metal or plastic frame (22). An interveningpliable metal or plastic spring (23) enables compression and expansionupon squeezing and releasing the forceps receptacles (24). Pads (25) areplaced at the contact surfaces of the lateral nasal wall and middleturbinate. These consist of a slightly compressible substance (e.g.,foam rubber) surfaced with a smooth thin nonadherent, nonabrasive filmso as to avoid trauma to the nasal lining. Preferably, the device shouldcompress to a width of less than 3 mm and should be able to expand to awidth that need not markedly exceed 10 mm.

FIGS. 7A-7C show application of the use of a posterior/inferiorturbinate retractors of the present invention. FIGS. 7A-7C depict across-section of the lateral wall (LW) and middle turbinate (MT) in thecoronal plane of the bulla. Notably, the posterior/inferior retractor(FIGS. 4-6) serves the same purpose as the anterior/superior middleturbinate retractor, but is placed in a separate location and may havethe advantage of remaining posterior to all surgical maneuvers insubsequent steps. As depicted in FIG. 7A, the posterior/inferiorturbinate retractor (21) is placed between the lateral wall (LW) and themiddle turbinate (MT). Placement of the posterior/inferior turbinateretractor (21) is inferior to the ethmoid bulla (not shown in FIG. 7A).It is then expanded (FIG. 7B) to retract the middle turbinate. FIG. 7Cdepicts an endoscopic view with the posterior/inferior turbinateretractor in place. The result of the retraction is to improve theexposure of vital sinus structures including the uncinate process (UP),ethmoid bulla (EB), hiatus semilunaris superior (HSS) and natural ostiumof the maxillary sinus (NOMS). Comparably, without the aid of aposterior/inferior turbinate retractor (FIG. 7D), these anatomicalstructures are substantially unexposed.

Because both middle turbinate retractors of the present invention yieldimproved exposure of the sinus surgical field, they may be useful inmore traditional endoscopic surgeries as well as methods described inthe present invention. It should also be noted that although theseretractors are deemed convenient for the methods of the presentinvention, as described below they would not considered necessary fortheir execution.

Access to the Maxillary Sinus

A substantial application for the minimally invasive sinus access of thepresent invention is to provide solutions to mild-to-moderate sinusitisin the maxillary and ethmoid sinuses. In preferred embodiments of thepresent invention, the procedures can be performed in the surgeon'soffice, under minimal anesthesia, and after moderate (rather thanextensive) medical options are exhausted. Such a procedure must (1) beeasy to learn by practitioners of current routine sinus surgical art;(2) produce reliable prolonged improvement after healing rapidly withlittle-to-no pain or bleeding; and (3) provide a quick return to normalactivity. As such, the procedure should resemble, as much as possible,the familiar approaches to the sinuses in question, and intranasaltrauma must be minimized, especially in the sinus outflow tracts and atthe ostium margin, where mucus first exits the sinus.

In a preferred embodiment of the present invention, the procedure of thepresent invention approaches the maxillary sinus natural ostiumtransnasally, from anterior to posterior, avoids traumatizing theoutflow tract of any known sinus, and allows direct visual verificationof a true natural ostium placement of the dilator before dilation isperformed. That is accomplished by an anterior transuncinate “keyhole”approach to the natural ostium of the maxillary sinus described indetail below. Safe, reliable perforation of the uncinate and dilation ofthe natural ostium and ethmoid infundibulum are obtained using newdevices of this invention as described below. This approach and thesedevices enable the performance of a reliable minimally invasivecorrection of maxillary sinusitis under minimal anesthesia.

Prior to addressing the uncinate process (UP) and ethmoid infundibulum(EI), it may be convenient to retract the middle turbinate as describedabove. However, middle turbinate retraction is not necessary forperforming the procedures described below.

Relevant anatomy around the maxillary sinus is illustrated in FIGS.8A-8C. FIG. 8A shows the typicalanteroinferomedial-to-posterosuperolateral view obtained during nasalendoscopy; FIG. 8B represents a medial-to-lateral sagittal view of therelevant structures of the middle meatus; FIG. 8C represents the samestructures in transverse view from superior-to-inferior. It is notedthat each procedure described below with respect to the maxillary sinusshows these three separate views for clarity. The patient's right sideis chosen for consistency and convenience. The figures show that theuncinate process (UP) is anterior and inferior to the ethmoid bulla(EB). The anterior attachment of the uncinate process (AAUP) and theposterior attachment of the uncinate process (PAUP) are depicted. Theethmoid infundibulum (EI) lies in the narrow space between the uncinateprocess (UP) and the lateral wall of the nose, just anterior to theethmoid bulla (EB) and can be seen most clearly in FIG. 8C. Themaxillary sinus (MS) connects to the natural ostium of the maxillarysinus (NOMS) which is located lateral to the uncinate process. Naturaldrainage of mucous from the maxillary sinus, indicated by the arrow inFIG. 8A, occurs through the natural ostium of the maxillary sinus (NOMS)into the ethmoid infundibulum (EI). The natural ostium of the maxillarysinus (NOMS) cannot be observed directly because it is blocked by theuncinate process (UP). The “keyhole” approach of the present inventionovercomes this problem and allows the surgeon a direct view of thenatural ostium of the maxillary sinus (NOMS) and ethmoid infundibulum(EI).

In accordance with one aspect of the present invention, access to theethmoid infundibulum (EI) is gained at the anterior-inferior extent ofthe uncinate using a backbiting hole punch of the present invention(FIG. 9A) to create a transuncinate “keyhole”. The intended site of thekeyhole is indicated with an asterisk in FIGS. 10A-10C, which show theanteroinferomedial-to-posterosuperolateral view, medial-to-lateralsagittal view, and the transverse view from superior-to-inferior,respectively. The backbiting hole punch (26) depicted in FIG. 9A enablesatraumatic access to the natural ostium. It is configured much like thebackbiting forceps used by most surgeons in the prior routine sinus art.Unlike that instrument, however, it perforates the uncinate near itsanterior attachment only, rather than removing it en route from theposterior margin. Perforating the uncinate process (UP) anteriorlyrather than dividing it transversely into superior and inferior “flailsegments” preserves the overall integrity of the uncinate mucosa andbony framework. This structural support is key to preserving surgicalmodifications that will be described below in the method of the presentinvention and avoiding complications of healing.

The backbiting hole punch (26) depicted in FIG. 9A consists of a mobiletapered flange (27) and a stationary platform (28) mounted on a shaft(29) that connects to handles (31) (not shown in FIG. 9A) that aremanipulated by the practitioner. FIGS. 9B-9D show a side view, a topview and an end-on view of mobile tapered flange (27), respectively.Likewise, FIGS. 9E, 9F, and 9G show a show a side view, a top view andan end-on view the stationary platform (28), respectively. A blow-up ofthe handles (31) is depicted in FIG. 9H. As depicted in FIG. 9H, thehandles (31) are located at the proximal end of the shaft (29). Thehandles (31) are manipulated by sticking two fingers is the holes andsqueezing the holes together. The instrument can be made wholly of rigidmaterial like metal or plastic but a portion of the shaft (29) may becomposed of a semirigid material with some flex such as plastic, fibercompound, or rubber, in order to facilitate intranasal maneuvering. Theshaft (29) may be straight or angled (30) up to approximately 20degrees. If an angled shaft is used, the angle allows the mobile flange(27) and the stationary platform (28) to be delivered into the targetarea of the nose parallel to the orbital wall, uncinate process, andmiddle turbinate, facilitating access and limiting trauma. Spreading thehandles (31) opens the gap angle (32) between the mobile flange (27) andthe stationary platform (28) and squeezing them together closes it. Uponclosure, a thin layer of material (in the method of the presentinvention, the thin bone and mucosa of the uncinate) is transfixed inbetween the flange (27) and platform (28) and creates a perforation(‘keyhole’) in the material as the blade (33) is pushed into thereceptacle (34). In these diagrams, the blade is depicted on theplatform (28) rather than on the mobile flange (27) so as to render themobile flange (27) as thin as possible, a desirable characteristic foratraumatically introducing it into the narrow ethmoid infundibulum (EI),as described below in the method of the current invention. Nonetheless,the orientation can be reversed, if desired. The tip (35) of the mobileflange (27) may be tapered to facilitate the aforementioned insertion.

The length of the mobile flange (27) is preferably in the range of about1.0 cm to about 2.0 cm. This length is chosen to maximize thepossibility that the perforating tip will reach the anterior attachmentof the uncinate when it is pulled to the anterior extent allowed by theuncinate atraumatically (see FIGS. 13A-13C and FIGS. 14A-14C) while atthe same time maintaining maneuverability within the nose. A hole ofapproximately 3 mm is chosen as this size easily admits the guide-freedilator of this invention (see FIGS. 15A-15C, below) and a 2.7 mmendoscope (widely available), but other sizes are admissible, includinga blade design that punctures without removing tissue (FIG. 91) or onethat removes a strip rather than a circle of tissue (FIG. 9J).

Referring again to FIG. 10B, the uncinate process (UP) has a shapesimilar to a boomerang with its arms directed anterosuperior andposterior, respectively. The entry site (indicated on FIGS. 10A-10C byan asterisk) of the hole punch mobile flange (27) is in the crotch ofthe boomerang and directed anteriorly toward the apex of the boomerang.As depicted in FIGS. 11A-11C, the mobile flange (27) of backbiting holepunch (26) is advanced into the posterior opening of the ethmoidinfundibulum (EI) well superior to the pathway of mucus exit from theposterior ethmoid infundibulum (EI) and levered gently to assess thelocation of the anterior and inferior attachment of the uncinate process(UP). This maneuver facilitates the anterior advance of the mobileflange (27) within the ethmoid infundibulum (EI) by stretching theuncinate process (UP) a bit medially and helps define the anterior andinferior attachments of the uncinate process (UP) where the “swingingdoor” of the uncinate process “hinges” with respect to its skullattachments (FIGS. 11A-11C). The hinge zone (marked in FIGS. 11A-11C)defines the anterior and inferior extent of the ethmoid infundibulum(EI). The natural ostium of the maxillary sinus (NOMS) is reliably founda few millimeters posterior to the anterior-inferior apex of the ethmoidinfundibulum (EI). As such the surgeon seeks to create the keyholeperforation as anterior and inferior as possible on the uncinate process(UP). He aims the tip (35) of the mobile flange (27) of hole punch (26)anterior and inferior toward the apex of the uncinate “boomerang,”roughly the intersection of the axes of the anterior and inferiorattachments of the uncinate (target sign in FIGS. 10A-10C). The tip (35)is advanced anteriorly and inferiorly by pulling the instrument towardthe surgeon. It will naturally stop at the anterior inferior extent ofthe infundibulum (FIGS. 12A-12C) and the keyhole perforation is createdthere by squeezing the finger action together to close the mobile flange(27) to the stable platform (28) of the backbiting hole punch (26),transfixing the uncinate process (UP) and excising the interveningtissue (FIGS. 13A-13C). The tip works much like a paper hole-punch,scrupulously protecting the orbit while creating a perforation(‘keyhole’) in the uncinate process (UP) in the appropriate,strategically located position. Reliably, this maneuver will place thekeyhole (KH) immediately medial to the natural ostium of the maxillarysinus (NOMS) or just anterosuperior to it (FIGS. 14A-14C). Such aposition is ideal to allow anterior to posterior access to and visualverification of the natural ostium of the maxillary sinus (NOMS).

After removal of the backbiter hole punch, a guide-free dilator of thepresent invention is used to restore the flow of mucous from themaxillary sinus to the nasal cavity. An embodiment of the guide-freedilator of is displayed in FIG. 15A. The guide-free dilator (39)consists of a rigid handle (40), preferably composed of metal orplastic, and a sufficiently rigid shaft (41), similarly composed, thatincorporates a specific distal angulation (42). The range of allowableangles may be anywhere from 0 to 145 degrees from straight, but ispreferably in the range of 30 to 60 degrees. The most preferredembodiment for general applicability in the sinuses is likely to be ator near 45 degrees. This fixed angulation (42) may be accomplished witha single integrated instrument as shown in FIG. 15A. Alternatively,multiple fixed angulations may be accomplished with a two-partembodiment (FIG. 15B). In this embodiment, a single semirigid catheter(44) can be clipped into a choice of several interchangeablehandle-shaft carriers (45), each of a distinct fixed angle, if suchversatility is desired. The combined instrument (46) would share theother characteristics of the integrated instrument and would be expectedto function similarly. It will be appreciated that the sufficientlyrigid shaft (41) of the guide free dilator (39) may have a minimalamount of malleability.

The dilator segment (43) of guide-free dilator (39) is shown in FIG.15C. The dilator segment (43) consists of a semirigid shaft (47),preferably composed of an external sheath of a plastic or fibercompound, ending in a spatulate or ellipsoid tip (48), and mounting aballoon (49). The semirigid shaft (47) is preferably made from apolymer. Preferable polymers include but are not limited to siliconerubber, polyurethane, polyethylene terephthalate, polyethylene,polypropylene, polyvinyl chloride, polymethyl methacrylate andpolytetrafluoroethylene. In the embodiment shown in FIG. 15C, theballoon (49) can be configured as a modified “figure-8” (50).Alternatively, in the embodiment shown in FIG. 15D, the balloon has anellipsoid configuration (51). The balloon is inflated and deflated byintroduction or withdrawal of fluid through the inflation port (52) viathe inflation conduit (53) (see FIG. 15A).

The guide-free dilator of the present invention has several uniqueproperties that enable it to operate optimally within the sinuses. Thehandle (40) is widened to accommodate its fit within the surgeon's hand.The guide-free dilator is only semirigid distally but remains stiff formost of its length, facilitating control, allowing the surgeon toretract or reflect intranasal structures to a degree and to preciselydirect the instrument using the dominant hand only. The device isintended to be used without a guide, and therefore, permits only minimalflexion, and only over a short segment of its total length. After theinstrument angles distally at the bend (41′) of substantially rigidshaft (41), it becomes semirigid in the dilator segment (43). Thisunique property is used in order to maintain enough rigidity to passalongside walls at sufficiently shallow angles of address but to flex atsufficiently perpendicular angles. This property facilitates findingostia and natural pathways through the paranasal sinuses and nose whileavoiding the creation of false passages. These characteristics make iteasier to navigate existing anatomy while avoiding damage. A spatulatetip (48) further reinforces these effects. As indicated above, theapproximate angle of curvature is preferably given at 30-60 degrees,most preferably at about 45 degrees. This general range of angulation isappropriate for the intended approaches to the superior and inferiorethmoid infundibulum, natural maxillary ostium, hiatus semilunarissuperior, ostia of the ethmoid bulla, and frontal sinus ostium.

In a preferred embodiment of the present invention, a balloon (49)functions as the actively dilating portion of the instrument. The lengthof the balloon is chosen to be approximately 1.0-2.0 cm, againappropriate for access to and dilation of the aforementioned structures.The range of 4-7 mm diameter for the balloon is chosen as appropriate tothe anatomy of the structures intended for dilation. The modified“figure 8” configurations of the balloon depicted in FIG. 15C may helpseat the balloon in the intended ostium, and if used, the dimensionspresented do help the surgeon to work in these narrow spaces. A standardellipsoid configuration of the balloon is also satisfactory. Althoughthe above dimensions were not chosen expressly for other paranasalsinuses, they do allow navigation of the posterior ethmoid and sphenoidas well. Furthermore, its design enables dilation of the maxillary sinusand ethmoid infundibulum completely independent of guides or guide wiresand only using the dominant hand, unique to the present invention, andunknown in the minimally invasive balloon dilation prior art.

FIGS. 16A-16C depict use of the guide-free dilator (39) of the presentinvention. The guide-free dilator (39) can be advanced readily throughthe keyhole (KH) perforation in the uncinate process (UP). Under directvision with an endoscope, the dilator tip (48) is advanced through theanterior uncinate keyhole (KH) into the mid-to-inferior ethmoidinfundibulum (EI) and the balloon (49) is expanded, medializing theuncinate process. The 45 degree (approximate) angulation of dilator tipto shaft (FIG. 15A) is expressly chosen to allow easy and accurateadvance of the tip into the ethmoid infundibulum (EI) via the keyhole(KH). This maneuver helps to open the final pathway of mucus drainagefrom the posterior infundibulum, best observed in FIG. 16B. The dilatoris then withdrawn slightly, the tip is turned laterally and inferiorlyand directed into the natural ostium of the maxillary sinus (MOMS) wheredilation can again be accomplished (FIGS. 17A-17C). Again, the 45 degreeangulation of the guide-free dilator (39) is ideal for this maneuver,with atraumatic, direct, and easy passage through the natural ostium ofthe maxillary sinus (NOMS) and into its antrum.

Of note, the dilator (39) of the present invention can also be used todilate the keyhole (KH), if desired (FIGS. 18A-18C). The dilation iseccentric as maxillary bone is far more resistant than uncinate. Theresulting dilation of the ethmoid infundibulum, natural ostium of themaxillary sinus, and, if desired, the keyhole are all visuallyverifiable with this approach.

If an accessory ostium (AO) is identified (FIGS. 19A-19C), it may bebroadly connected to the natural ostium of the maxillary sinus (NOMS) atthis point, according to the surgeon's discretion. This option is deemeduseful to exercise in many patients and is unique to the presentinvention in the balloon dilation art.

There are several key advantages of the present invention for treatingobstructed maxillary sinuses:

-   -   1. Ease of use: For each maneuver of the present invention, the        surgeon uses the nondominant hand purely for manipulation of the        endoscope and the dominant hand purely for manipulation of a        single surgical instrument. Both minimally invasive approaches        of the prior art (see U.S. Pat. Nos. 7,500,971 and 7,559,925)        use tubular guide catheters to direct the dilator appropriately,        requiring more surgical field clutter and hand-switching        maneuvers. These catheter-guide based systems are well-suited        for (and, indeed, adapted from) percutaneous endovascular        procedures like angioplasty, but foreign to sinus surgeons        accustomed to instruments that enable fine movements of the        fingers to translate directly and reliably into equally fine        movements of the working tip of that instrument, and to do so        using the dominant hand exclusively.    -   2. Direct visualization of the operative site: In the present        invention, the surgeon can see the natural ostium before        manipulating it and the approach is, conveniently, along the        axis of the endoscopic view into the nose. In the intranasal        procedure of the prior art, the natural ostium is never actually        seen, but is presumptively identified by the verified presence        of the guidewire in the maxillary sinus after blind passage (see        U.S. Pat. Nos. 7,500,971 and 7,559,925).    -   3. Avoidance of trauma to key structures: The method of the        present invention gains access to the natural ostium of the        maxillary sinus without trauma to any areas that participate in        mucus drainage from that sinus. In contrast, the guide-catheter        system of the prior intranasal art requires a near-180 degree        turn within the narrow confines of the middle meatus, a        cumbersome approach that unavoidably traumatizes the ethmoid        bulla and outflow tract of mucus exiting the maxillary sinus.        Although we are proceeding posterior to anterior with the        backbiter of the present invention, due to its design and        surgeon control, it is essentially atraumatic in its passage.        Further, one advances the backbiter from a point much higher in        the posterior infundibulum than is used by the nose for mucus        drainage, an area that is, on the contrary, necessarily        traumatized by the guide, guidewire, and for that matter,        withdrawal of the balloon post dilation in the method of prior        intranasal art.    -   4. Identifying and appropriately treating accessory ostia: As        noted above, accessory ostia are frequent anatomic findings.        Mistaken dilation of these structures to the neglect of the        natural ostium results in one of the commonest adverse        complications of maxillary sinus surgery (mucus recirculation        and worsening of maxillary sinusitis). The method of the present        invention allows unequivocal identification of the natural        ostium and easily enables identification of accessory ostia The        intranasal procedure of the prior art may actually be more        likely to dilate an accessory ostium, if present, than the        natural ostium because the accessory ostia are frequently larger        and invariably lie along the path that the guide wire follows in        blind search for the natural ostium.    -   5. The procedure is easily combined with other sinus/nasal        procedures: Unlike the canine fossa procedure (U.S. Pat. No.        7,520,876) of the prior art, the method of the present invention        employs a purely intranasal approach that easily marries with        the other intranasal procedures that usually are performed        alongside the maxillary procedure. In addition to the simplicity        of the approach, the method of the present invention uses the        same core device for access to the other paranasal sinuses (as        will be seen below), in marked distinction to the canine fossa        approach and to the multiple guides employed by the intranasal        approach of the prior art.

Access to the Anterior Ethmoid Sinuses

The important anatomical features discussed in this section aredisplayed in FIGS. 20 and 21A-C. FIG. 20 is a view from medial tolateral of the structures lateral to the middle turbinate with theturbinate itself removed. Both the superior root of the middle turbinate(SRMT) and the posterior root of the middle turbinate (PMRT) can be seenin the diagram. The solid arrows indicate the path of mucous drainage.As will be discussed in more detail below, mucous from the anteriorethmoid sinus cells drains primarily through the ethmoid bulla ostium(EBO) into a narrow passageway between the ethmoid bulla (EB) and thebasal lamella (BL), referred to as the hiatus semilunaris superior(HSS). Accessory ostia (AO) cam also be seen in the figure. The ethmoidbulla (EB) and accessory ostia (OA) are found in the posteromedial wallof the ethmoid bulla (EB). The ostial zone (OZ) in the ethmoid bullawall is depicted in the diagram. FIG. 21A shows the typicalanteroinferomedial-to-posterosuperolateral view obtained during nasalendoscopy. FIG. 21B represents a medial-to-lateral sagittal view of therelevant structures of the middle meatus. FIG. 21C represents the samestructures in transverse view from superior-to-inferior. These threeviewpoints will be used to depict the embodiments discussed below. Inthese figures, the solid arrows indicate the path of mucous drainage.

The anterior ethmoid is that group of pneumatized cells of the ethmoidthat drain anterior to the basal lamella (BL), a roughly vertical thinbony wall that comprises the attachment of the middle turbinate to thelateral wall of the nose (FIG. 20). Those cells are often involved withinflammation synchronously with their maxillary sinus counterpart,frequently to the exclusion of the posterior ethmoid (PE)—or, that partof the ethmoid sinuses posterior to the basal lamella (FIG. 20)—hence,the distinction in clinical nomenclature within the ethmoid. A preferredembodiment of the present invention allows for systematically addressingthe anterior ethmoid seamlessly with the maxillary sinus. Inconventional minimally invasive sinus surgery (as per Messerklinger),the uncinate process (UP) is completely removed and the ethmoid bulla(EB) and adjacent anterior ethmoid air cells completely marsupialized(i.e., widely opened to broadly drain into the main vault of the nose.)With perhaps other minor alterations, that succeeds in opening all ofthe major cells and recesses of the anterior ethmoid. That procedure islargely successful in solving the inflammatory problems it sets out totreat. Those traumatic efforts can be painful for the patient, and inany case, moderate degrees of anesthesia, bleeding or nasal packing,prolonged stuffiness, and some missed work/activities are to beexpected. The present invention achieves the same clinical resultswithout those demerits.

As discussed above, there is greater variability and uncertainty as tothe identity of the true drainage pathways for the anterior ethmoid.There also is variability among patients in the structure of theaptly-named ethmoid labyrinth. Many surgeons believe that the ethmoidinfundibulum (EI) is the primary drainage site for the anterior ethmoid.Indeed, that is the usual drainage site for the agger nasi cell(s) (AN)(FIG. 20). The hypothesis in general, however, likely is unsound becausethe ethmoid bulla antrum rarely has a drainage communication with theethmoid infundibulum (a septum of bone usually separates the twospaces), and when there is such a communication, it drains only a smallisolated chamber of the ethmoid bulla (EB). In general, the main outletfrom the ethmoid bulla (EB) and its dependent adjacent anterior ethmoidair cells is an ostium in the posteromedial wall of the ethmoid bulla,referred to as the ethmoid bulla ostium (EBO) (FIG. 20). Although theethmoid bulla ostium (EBO) is not rigorously defined in the literature,it is invariably present, occasionally with a second or accessoryostium.

As depicted in FIGS. 21A-C, Mucus exits the ethmoid bulla ostium (EBO)into a narrow crescentic space between the posteromedial wall of theethmoid bulla (EB) and the anterolateral wall of the basal lamella (BL)called the hiatus semilunaris superior (HSS). These anatomicobservations are well-supported by published work dating back over onehundred years. The careful reader will note the analogy between thedescribed drainage pathway in the anterior ethmoid and that previouslyelucidated for the maxillary sinus. In the anterior ethmoid, as in themaxillary, a well-defined ostium drains into a narrow secondary space.In the maxillary sinus, a successful method for augmenting flow willsimultaneously open the natural ostium and ethmoid infundibulum (EI), asoutlined earlier; in the anterior ethmoid sinuses, the method must openthe ethmoid bulla ostium (EBO) and hiatus semilunaris superior (HSS).

In the current state of the art, marsupializing the anterior ethmoid isaccomplished by removing most of the walls or septations of the anteriorethmoid with a microdebrider, cutting forceps, or some combinationthereof. For those few surgeons who feel comfortable addressing thehiatus semilunaris superior (HSS) specifically, the same instrumentationis used to remove the medial wall of the ethmoid bulla (EB), leaving theopening in continuity with the hiatus. With current instrumentation, thehiatus area is opened by traumatizing it, thereby temporarilyobstructing it with eschar (and possibly permanently with synechiae).There also is the typical bleeding, pain, healing time, need foranesthesia, and the use of stents or packing, all of which would bebetter to minimize or avoid. Most of these problems can be avoided by aminimally invasive approach that seeks to dilate the hiatus semilunarissuperior (HSS) and ethmoid bulla ostium (EBO) without significantresection. To date, no such procedure exists in the prior art of sinusostia dilation.

In a preferred embodiment of the present invention, the anterior ethmoidis addressed without necessitating prolonged healing by directlydilating the ethmoid bulla ostium (EBO) and the hiatus semilunarissuperior (HSS). The ethmoid bulla ostium (EBO) is generally found on thesuperior posteromedial aspect of the ethmoid bulla (EB), and as such, isusually hidden from direct endoscopic view in the intact patient (FIG.21A, endoscopic view). In accordance with the present invention, thehiatus can often be successfully entered from the medial approach,described below. If the medial approach is not easily successful, and inaccordance with another aspect of the present invention, the surgeon canreliably perforate the anterior surface of the ethmoid bulla (EB)inferiorly and probe under direct vision superiorly to access theethmoid bulla ostium (EBO) and through it, the hiatus semilunarissuperior (HSS). As discussed below, such an anterior keyhole can also beused in conjunction with a medial approach to provide direct visualconfirmation that the ethmoid bulla ostium (EBO) has been entered fromwithout.

The medial approach is depicted in FIGS. 22-25. For clarity, thesefigures each show three different views of the relevant anatomy, whichare identical to the views shown in FIGS. 21A-C. The procedure maybegin, in identical fashion to that described above for the maxillarysinus, with middle turbinate retraction (FIGS. 3 and 7). Anesthesia isachieved locally and the middle turbinate is retracted out of the way.In this procedure, the retractor is of particular use in that here werequire as much medial exposure of the ethmoid bulla as possible, andthe middle turbinate otherwise obscures this area.

Next, the hiatus semilunaris superior (HSS) is addressed from the medialapproach. Turning to FIGS. 22A-C, curvilinear recess between the basallamella (BL) of the middle turbinate and the posteromedial wall of theethmoid bulla (EB) is entered with one or both ends of the medialethmoid probe of the present invention. The medial ethmoid probe (60) isdisplayed in FIG. 26A. This probe has a handle (61) and shaft (62 and62′) on both sides of the handle. The shaft is made of a rigid materialsuch as metal or plastic. The distal segment (63 or 63′) of either endmay be of rigid or semirigid material. The distal segment is preferablymade from a polymer including but not limited to silicone rubber,polyurethane, polyethylene terephthalate, polyethylene, polypropylene,polyvinyl chloride, polymethyl methacrylate and polytetrafluoroethylene.The distal segment (63) curves to a final angle (64) of less than 110degrees to the axis of approach. Preferably, the angle (64) is between20 degrees and 80 degrees. More preferably, the angle (64) is between 30and 60 degrees. FIG. 26B shows a distal segment (63) that is angledsuperiorly approximately 30 degrees (64) from the axis of approach. Itis noted that the angles (64 and 64′) may be the same or different. Thelength of the distal segment (63 or 63′) preferably ranges fromapproximately 0.5 cm to 2.0 cm, more preferably from 0.7 cm to 1.5 cm,and most preferably about 1.2 cm. The materials, curvatures, angles, andlengths as defined facilitate atraumatically maneuvering the distalsegment within the hiatus semilunaris superior (HSS) to engage theethmoid bulla ostium (EBO) with the curved tip (66), shown in highermagnification in FIG. 26C

In one embodiment of the present invention, the concave surface of thedistal tip (66) and distal segment (63) may be wedge-shaped in profile,to facilitate deforming or stretching the medial margin of the ethmoidbulla ostium (EBO) when the instrument is pulled toward the operatorwhile engaging the ostium (see FIGS. 23A-23C and discussion below.) Thefunction of the medial ethmoid probe (60) is to palpably identify anostium concealed (as it usually is) on the posterior aspect of theethmoid bulla (EB) and to enlarge it medially and anteriorly so that itcan be seen and therefore treated more definitively.

Manipulation of the medial ethmoid probe (60) is depicted in FIGS.22A-22C. In the method of the present invention, the medial ethmoidprobe is grasped by handle and the shaft and distal segment areintroduced into the nose. The distal segment (63) of the medial ethmoidprobe (60) is inserted into the hiatus semilunaris superior (HSS) andwith the manipulated such that the curved tip (66) engages the rim ofthe ethmoid bulla ostium (EBO). The procedure is facilitated owing tothe angulations and material composition outlined previously for themedial ethmoid probe (60). This interaction is easily palpated andoccasionally directly visualized. If a shallow angulation (64) of medialethmoid probe (60) (e.g., 30 degrees) is not able to engage the ostium,a steeper angle (e.g., 60 degrees) is used.

In most cases, the ethmoid bulla ostium (EBO) can be identified at thispoint and stretched open with a gentle posterior to anterior traction,indicated by the solid arrow in FIGS. 23A-23C. In FIGS. 23A-23C, thestarting point of medial ethmoid probe (60) is shown with dotted linesand the ending point is depicted with a solid line. The tractionmaneuver is facilitated by a cutting edge on the inner curvature of thedistal tip (66) and distal of the medial ethmoid probe (60). Onceidentified and gently stretched, the ethmoid bulla ostium (EBO) of thehiatus can usually be seen. Whether or not the ostium is directlyvisualized at this point, the tip of the guide-free dilator (39) of thepresent invention can be passed into the hiatus semilunaris superior(HSS)—i.e., the space between the ethmoid bulla (EB) and the basallamella (BL) and expanded (FIGS. 24A-24C). The guide-free dilator (39)is depicted in FIG. 15A and was discussed in reference to the maxillarysinus embodiments. Expansion of the guide-free dilator (39) leads todilation of the hiatus semilunaris superior (HSS), widening the narrowcleft into which the ethmoid bulla ostium (EBO) drains and improvingfurther access to the ostium itself. Now that the ethmoid bulla ostium(EBO) can, in most cases, be directly seen, it is entered under directvision with the tip of the guide-free dilator (39) and dilated (FIGS.25A-25C). Alternatively, cannulating and dilating the ostium with theguide-free dilator of the present invention may succeed in also dilatingthe hiatus semilunaris superior (HSS) in a single-maneuver if the ostiumcan be easily visualized after the stretching maneuver outlined earlier.Regardless, as shown in FIGS. 25A-25C, expansion of the dilator widensthe hiatus semilunaris superior (HSS) leading to a zone of deformity(shaded region in FIGS. 25A-25C).

Despite appropriate efforts, the medial approach occasionally will notgain reliable access to the ethmoid bulla ostium (EBO), usually becausethe ostium is placed exceptionally superior and lateral on the posteriorwall of the bulla. In such cases, in accordance with another aspect ofthe present invention, an anterior keyhole perforation is created. Theanterior keyhole approach is preferably performed after dilation of thehiatus semilunaris superior (HSS) using the medial approach describedabove. Alternatively, the anterior keyhole approach may be performedprior to dilation of the hiatus semilunaris superior (HSS).

The anterior keyhole approach is depicted in FIGS. 27-33. As describedabove, each of these figures depicts three separate views of therelevant anatomy surrounding the ethmoid bulla (EB). For ease ofapproach, the surgeon attempts to remain as lateral as possible, whilestill medial to the free posterior margin of the uncinate process (UP).The point (marked by asterisk in FIG. 27) chosen is also just below the“equator” of the ethmoid bulla (FIG. 27A-27C, dashed line)—i.e., theanterior extent of the convexity of the anterior wall of the bulla atabout the midpoint of its inferior-to-superior height yet above thepathway of mucus exit from the ethmoid infundibulum (EI). As a practicalmatter, this places the perforation in the inferolateral quadrant of thevisible anterior wall of the ethmoid bulla (EB). The chosen site has theadvantage of affording the best view of any ostium likely to escapeprobing from the medial aspect (i.e., a superior and lateral ostiumplacement) while also remaining out of any known common drainage pathwayfor the anterior ethmoid, frontal, or maxillary sinuses.

As shown in FIGS. 28A-28C, a perforation is made in the wall of theethmoid bulla (EB) at the site indicated in FIGS. 27A-27C. Such aperforation may be accomplished using the ethmoid keyhole probe of thepresent invention, depicted in FIG. 34. Ethmoid keyhole probe (72) iscomposed of entirely rigid materials and consists of a handle (73) witha thin shaft (74 and 74′) on both ends. One end mounts a perforator tip(75) with a stop collar (76). The perforator tip terminates in a sharppointed end (77) that is ideal for making a small perforation in thebone. The distance from the pointed end (77) to the stop collar (76) ispreferably less than 1.0 cm and most preferably about 0.5 cm. The otherend mounts a dilator tip (78) that is bluntly tapered at the distal end(79) and rounded at its proximal end (80). The tapered distal tip (79)has a smaller diameter than the rounded proximal end (80) which isitself not more than 0.5 cm in diameter. As will be apparent from thefigures below, the ethmoid keyhole probe (72) depicted in FIG. 34 servesthe dual purpose of making the perforation in the wall of the ethmoidbulla (EB) and dilating the resultant perforation. However, inaccordance with another aspect of the present invention, the perforationand dilation can be accomplished with separate instruments.

Perforation of the wall of the ethmoid bulla (EB) using the anteriorethmoid keyhole method of the present invention is depicted in FIGS.28A-28C. In these figures the pointed end (77) of the perforator tip(75) of the ethmoid keyhole probe (72) engages the anterior wall of theethmoid bulla (EB) at the chosen site (see FIGS. 27A-27C) and penetratesthe wall into the antrum of the ethmoid bulla (EB). The stop collar (76)limits the extent of penetration.

As shown in FIGS. 29A-29C, the ethmoid keyhole probe (72) then iswithdrawn, inverted and the dilator tip (78) of the ethmoid keyholeprobe (72) is introduced completely into the ethmoid bulla antrumthrough the perforation. The ethmoid keyhole probe (72) is thenwithdrawn (FIGS. 30A-30C), everting the mucosa of the wall. At thispoint, the perforation can be enlarged with the guide-free dilator (39)of the present invention (FIGS. 31A-31C). Alternatively, as depicted inFIGS. 32A-32C, dilation of the perforation may be accomplished with aconventional sphenoid punch (83). For example, a 19.5 centimetersphenoid punch can be obtained from V. Mueller, catalog no. RH550-452.Note that while the guide-free dilator (39) expands to a predetermineddiameter, the sphenoid punch (83) can incrementally remove smalleramounts of tissue to a desired stopping point, at the discretion of thesurgeon. Although this yields control of size, it does so by cuttingrather than stretching tissue and therefore likely generates a littlemore bleeding than the dilator.

Referring back to FIG. 31 or 32, dilation of the keyhole should provideenough exposure to identify, cannulate, and dilate the ethmoid bullaostium (EBO). Hence, similar to the maxillary sinus embodimentsdiscussed above, the guide-free dilator (39) is introduced through theperforation and the ethmoid bulla ostium (EBO) is dilated (FIGS.33A-33C). It should be noted that the success of this approach maydepend on previously achieving the dilation of the space of the hiatussemilunaris superior (HSS) from the medial approach, much as the successof maxillary sinus approaches depends not only on dilation of thenatural ostium but also on dilation of the ethmoid infundibulum (EI).(cf. FIGS. 16A-16C and FIGS. 24A-24C and FIGS. 25A-25C). The ethmoidkeyhole approach gives the surgeon exposure to the ostia from bothanterolateral (inside the ethmoid bulla) and posteromedial (outside thebulla, in the HSS). In many cases, this increased exposure will becrucial to knowing the job was accomplished. One can tell by workingfrom the outside first, as in the described method, and if adequateostium dilation can not be effected easily, gain the improved exposurethrough the keyhole, while still limiting or eliminating resection oftissue.

The other major cells of the anterior ethmoid bear some discussion. Thespace often styled the “sinus lateralis” can also be subdivided intofairly distinct suprabullar and retrobullar recesses. Fortunately, thesespaces have fairly broad communication with the nasal vault in mostcases; in any case, significant disease in these areas does not lenditself to minimally invasive approaches. Similarly, other more distalcells of the anterior ethmoid often communicate with the aforementionedspaces and the ethmoid bulla (EB). Accordingly, procedures describedabove for dilating the ethmoid bulla ostium (EBO) and the hiatussemilunaris superior (HSS) should mitigate blockage of these cells aswell.

The agger nasi (AN) also bears special mention. When present, the aggernasi (AN) is found lateral to the superior uncinate and has a separatedrainage pathway inferiorly, into the ethmoid infundibulum (EI). It caneasily be dilated during the maxillary procedure, if desired, bydirecting the tip of the guide-free dilator (39) of the presentinvention superiorly, into the antrum of that cell. The proximal end ofthe frontal recess is usually positioned posteromedial to itsposteromedial wall; hence, the agger nasi (AN) and frontal sinus areoften involved synchronously with inflammation. For this reason, onemust be quite careful regarding the use of dilators in this area, so asnot to have the improved drainage of one area compromise the patency ofthe other. Alternatively shaped guide-free dilators of FIGS. 35A-B maybe of particular use in this area as they allow for more limited,small-diameter dilation. Such a dilator tip might be mounted on acarriage similar to that of the backbiting hole punch (FIG. 9H) or ofthe drug delivery devices (FIGS. 38A and 39A) of the present invention,enabling similar maneuverability within the nose. The distal tip (90) isrounded in order to allow atraumatic advancement into the visualizedostium. Just proximally, the dilating flanges (91) taper to a neck (92)to facilitate seating them in the ostium when they are expanded todilate it (FIG. 35B). Many different mechanisms to obtain the expansionof the flanges (91) are contemplated.

Access to the Frontal Sinus

As noted above, the frontal sinus is sometimes inflamed in concert with,and probably as a result of, inflammation in the anterior ethmoid. Assuch, in the minimally invasive arena, frontal sinusitis can often betreated purely by appropriate treatment of the anterior ethmoid, asoutlined above, or with procedures of the prior art. There arecircumstances, however, in which direct dilation of the frontal sinusostium is desirable. An appropriately trained practitioner of theroutine sinus art can directly visualize the frontal ostium in apredictable manner using a 70 degree endoscope. Subsequently, the curvedrigid-semirigid balloon dilator (39) of the present invention can bepassed into the ostium under direct vision and without resort to aguide. As in the above approaches, a significant advantage to thedilator of the present invention is that it can be manipulated just likethe probe employed in frontal sinus identification in routine sinusprocedures.

The frontal sinus procedure of the present invention is depicted inFIGS. 36 and 37. These figures each show two views of the relevantanatomy around the frontal sinus, an endoscopic view (70 degrees) (FIGS.36A and 37A) and a sagittal projection (FIGS. 37A and 37B). In theFigures, the relevant anatomy is indicated, particularly the frontalsinus (FS) and frontal ostium (FO). The shaded cells in the figures aresmall ethmoid air cells. The frontal approach is likely bestaccomplished before the maxillary sinus and ethmoid infundibulum areaddressed. After anesthesia and middle turbinate retraction areachieved, as described above, a 70 degree endoscope is advanced into themiddle meatus just medial to the mid portion of the uncinate process,with the view directed superiorly (FIG. 36B). The frontal ostium isgenerally found posteromedial and superior to the posteromedial andsuperior aspect of the agger nasi cell (FIG. 36A). The guide-freedilator (39) can then be directed superior, lateral, and anterior andpassed into the ostium under direct endoscopic vision (FIGS. 37A-37B).The appearance and position of the ostium are fairly characteristic tothe trained practitioner of the prior routine sinus art, but, as theremay be confounding adjacent small ethmoid cells present, it would beappropriate at this point to verify placement in the true frontal sinusostium via fluoroscopy or other means. Dilation can then beaccomplished. Anatomic variations can be seen. Exhaustive treatment ofthe variations is beyond the intended scope of this description, butsuffice it to say that the person of ordinary skill in the art willrecognize that the dilator of the current invention can be used to treatother anatomic locations of the ostium in analogous fashion to the abovedescription.

Access to the Posterior Ethmoid

Definitive and directed treatment of this area is not often required inthe minimally invasive arena, but certainly is amenable to the use ofthe guide-free dilator device of the current invention. The drainagepathways of the posterior ethmoid are quite variable and need to beassessed on a case-by-case basis. One constant to the variation is thatmucociliary flow proceeds from the superolateral to the inferomedialdirection, exiting in the superior meatus. This area can beendoscopically assessed using a 70 degree endoscope passed medial to themiddle turbinate and with the view directed laterally. The ostia andrecesses of the posterior ethmoid often can be seen with this approachand dilation can be accomplished with the guide-free device under directvision as deemed necessary and appropriate.

Access to the Sphenoid Sinus

As in the posterior ethmoid sinuses, the sphenoid does not frequentlyrequire treatment in the minimally invasive arena. Nonetheless, thesphenoid sinus ostium can be identified posterior and superior to thebody of the superior turbinate by appropriately trained practitioners ofthe routine sinus surgical art. This site is visualized with a 0 or 30degree endoscope passed medial to the middle and superior turbinateswith the view directed laterally, if the angled scope is needed. Theguide-free dilator (39) of the current invention is well-suited todirect passage into the visualized ostium. As in the frontal sinus,proximity to vital structures and the concomitant hazard of significantmorbid complications suggests that external verification of placementusing fluoroscopy or other methods may be desirable in some cases beforedilation is undertaken.

Delivery of Targeted Pharmacotherapy

As described in the Background section, it would be desirable tofacilitate treatment of the sinuses with topical agents as, in anappropriate iteration, one would expect such treatment to be moreeffective and have fewer side effects than can be observed using an oralroute of administration. Ideally, the means for delivery could be usedon a repeated basis, if needed, with topical or no anesthesia, in anoffice setting. To that end, there is a need in the prior art forminimally traumatic and reliable access to the paranasal sinuses and fordrug placement devices that are cost-effective and do not require laterremoval.

The anterior keyhole approach to the maxillary and anterior ethmoidsinuses and the medial approach to the ethmoid bulla outlined abovesatisfy the requirement for minimal trauma and reliability. Guide-freedrug placement devices of the present invention allow the practitionerto take advantage of the keyhole access or direct visualization of thesinus ostia to place pharmaceuticals in solid, powdered, semisolid, orliquid biodegradable matrices within the appropriate sinus cavities. Offurther benefit, the devices enable placement of the pharmaceuticalstrategically, in distal areas of the sinuses in question, so as to takeadvantage of the natural mucociliary clearance action of the sinuslining to spread the therapeutic agent throughout the sinus.

The action of placement of the therapeutic agents in each relevant sinusis entirely analogous to that noted above for the dilation of the sinusostia, and is in general even simpler. The guide-free drug placementdevices of this invention take advantage of the same angled anatomy asemployed by the guide-free dilator of this invention and are easilymanipulated by practitioners in similar fashion to accustomed probes ofthe routine sinus art.

In the maxillary sinus procedure of the present invention, topicalinfiltration anesthetics are placed. Infiltration anesthetics may alsobe used, but may not be needed if a keyhole or other antrostomy isalready present. The creation of a keyhole is outlined in detail aboveand surgical maxillary antrostomies can be created according to theroutine surgical art. Having established either type of opening into thesinus or by means of a naturally occurring accessory ostium, the surgeonutilizes a drug insertion device of the present invention to introduceeither a drug or a drug-delivery device of the present invention intothe maxillary sinus antrum. Two embodiments of drug insertion devicesused in accordance with the present invention are depicted in FIGS. 38and 39.

The drug insertion delivery instruments (100) depicted in FIGS. 38A and39B share a number of common characteristics. Each consists of a rigidshaft (101) mounted on a handle assembly (102) held by the surgeon. Herethe handle is depicted using a traditional syringe action with fingerholes (103) to accommodate the surgeon's index and middle fingers and aplunger (104) for the thumb. The plunger (104) is squeezed toward thefinger holes (103), advancing the piston (105) through the cylindricalshaft (101). Other mechanisms for the handle assembly are permissible aslong as they succeed in advancing the piston (105). The shaft (101)angles distally at the intermediate segment (107). Appropriateangulations at this site are similar to those for the guide free dilatordescribed above, but here the ideal angle is between about 55-60degrees. This angle is specifically chosen to enable drug or drug deviceinsertion through the keyhole in the maxillary sinus while also beingable to easily accommodate a standard surgical maxillary antrostomy,naturally occurring accessory ostium, anterior ethmoid keyhole or patentmedially dilated ethmoid bulla, as previously described in the methodsof the present invention. All of the preceding items are of rigidconstruction, preferably using metal or plastic, except for the piston(105), which is flexible so as to accommodate the angled intermediatesegment (107) of the shaft (101). Flexible plastic or malleable metalembodiments (as in a wire or spring) of the piston (105) are possible.In each device embodiment, the instrument terminates in a distalreceptacle (108). The distal receptacle (108) segment is shown in thedotted circle of FIGS. 38A and 39A. The length of the receptacle (108)is preferably in the range of 1.0-2.0 cm with the most preferred lengthabout 1.5 cm. The width is approximately 5 mm. These dimensions arechosen to allow the insertion device to negotiate the middle meatus andkeyhole in a patient with otherwise intact anatomy.

The distal receptacles (108) are rendered differently in the twoembodiments depicted in FIGS. 38A and 39A. In the FIG. 38A embodiment,the receptacle (108) consists of several (at least 3) flexible flanges(109) which curve to grasp the drug (110) or drug delivery device. Asshown in FIG. 38B, the drug (110) is initially held in distal receptacle(108) prior to drug delivery. As depicted in FIG. 39C, the flexibilityof the flanges (109) allow them to spread apart when the piston (105)pushes the drug (110) or drug delivery device (e.g., drug in controlledrelease carrier) against the incurving distal tip (111), thus allowingthe drug (110) or drug delivery device to be extruded from the now-openend of the insertion device. Again, flexible metal or plasticembodiments are preferable.

In the FIG. 39 embodiment, the receptacle (108) consists of a sleevewhich wholly encompasses the drug or drug (110) delivery device butotherwise functions similarly to that in FIG. 38. The mechanism ofaction of pushing out the drug (110) or drug delivery device is shown inFIGS. 39B and 39C.

In the method of the present invention, the drug insertion instrument(100) is grasped by the handle assembly (102). The shaft (101),intermediate segment (107), and receptacle tip (108) of the druginsertion instrument (100) are introduced into the nose with a drug(110) or drug delivery device of choice loaded in the receptacle (108).The receptacle is directed through the keyhole (described above),antrostomy, or accessory ostium into the maxillary antrum (FIGS. 40 A-C)in entirely analogous fashion to the introduction of the dilator in thepreviously described maxillary procedure of the present invention. Asnoted in the above description of the drug insertion instrument (100),the handle assembly (102) is manipulated so as to advance the piston(105) through the shaft (101), causing the drug (110) or drug deliverydevice to be inserted into the antrum (FIGS. 38C and 39C). The insertiondevice is then removed. The natural effect of gravity and the inferiororientation of the tip deliver the drug in the inferior apex of thesinus. Conveniently, this is an advantageous position for concentratingthe drug where it is most helpful. The gravitationally dependent areasof the maxillary sinus are generally the most involved withinflammation. The drug may then distribute more generally viamucociliary action of the sinus lining.

In the anterior ethmoid, topical or local infiltration anesthetics alsocan be used. Again, the middle turbinate will generally not need to beretracted in a stand-alone drug-placement procedure. If medial access tothe bulla is already established, as outlined earlier in the method ofthe present invention (FIGS. 22-25), the drug insertion device can beintroduced between the middle turbinate body and the bulla; thereceptacle (108) is then advanced through the enlarged ethmoid bullaostium (EBO) and directed lateral and posterior (FIGS. 41A-C). The drug(110) or drug delivery device is then released into the ethmoid bullaantrum. This lateral placement takes advantage of natural mucociliarymovement. The insertion device is, however, versatile enough to allowstrategic placement in a number of different directions. It is ideallysuited, for example, to utilize the anterior keyhole of the bulla, ifpreviously created (method outlined above), as access to the antrum ofthe ethmoid bulla. In this method, the receptacle tip (108) of theinsertion device is introduced straight through the anterior wall of thebulla via the keyhole, entirely analogous to the use of the dilator inthe anterior ethmoid keyhole method of the present invention (see FIGS.31A-C).

The frontal, posterior ethmoid and sphenoid sinuses can be accessed withthe placement device in entirely analogous fashion to the dilationprocedures outlined above.

The present invention foresees the utility of sinus-specificbiodegradable matrices for the delivery of topical pharmaceuticals forthe sinuses. One would require that the matrix release medication overthe interval of days-to-weeks, in sufficient concentration for effect,but without toxicity to the sinus mucosa. In particular, functionaldisruption of the gel-mucus interface with the cilia or alterations ofciliary motility would not be well tolerated. Of interest, substantiallysmaller doses of the active agents (e.g., antibiotics) than normallyused orally might be highly effective topically given the immenseadvantage of concentration of action in this arena. Appropriate vehiclesfor drug release might include timed-release tablets, ointments, gels,creams, liquids, or powders. The parameters under which the release isachieved will be unique to the sinuses, both for the reasons notedabove, and for the fact that the conditions anticipated in the sinuseshave little in common with the enteric or intramuscular environmenttypically encountered by timed-release agents in humans.

Each of the drug delivery vehicles discussed above have their ownproblems, however. All are susceptible to rather rapid clearance by thenatural mucociliary clearance function of the sinus lining. Furthermore,in the maxillary sinus with a large accessory ostium, or one previouslyoperated with traditional techniques, and for the anterior ethmoidsinuses in general, gravity as well as mucociliary clearance may lead toearly egress without some enhanced means of retention. Ideally, and asoutlined below in an embodiment of the present invention, is abiodegradable retention framework that degrades at different rate thanthe drug matrix.

A drug delivery device of the present invention consists of a typicaltimed-release drug containing matrix coupled with a resorbableframework. The pharmaceutical industry has, over the years, developedbiodegradable matrices for drug delivery, and the antibiotics andsteroids considered for use in this arena are demonstrably active in thenose and have been coupled with biodegradable matrices in numerous oralpreparations. As for the coupled framework, many materials are known todegrade in the nose over weeks-to-months, the ideal time interval forsuch a framework, including oxidized cellulose and polymerized sugarsused in suture material. The polymers, in particular, maintain muchstructural integrity throughout a large part of the degradation intervaland are relatively inert to nasal and sinus mucosa.

Several iterations of this drug delivery device have been conceived;these embodiments are illustrated in FIGS. 42-44. Each of theseembodiments are configured so as to be utilized with the drug insertioninstrument (100) of the present invention, but this relationship neednot be exclusive. The central idea of a differentially degradingintegrated retention framework coupled to a more traditional timedrelease drug matrix can certainly be adapted to other insertion systems,if desired, while still retaining its central advantages for topicaltherapies specifically in the sinuses. Ideally, any such device can beimplanted easily under local anesthesia in the office, will elute drugover several weeks, and will resist the natural sinus mucociliaryclearance to remain in place while pharmacologically effective. Theillustrated embodiments and, by extension, analogous iterations, willfulfill these objectives admirably.

FIG. 42A shows the first embodiment of the drug delivery device of thepresent invention, consisting of a drug containing matrix (120) with anembedded degradable framework (121). The framework (121) is anchored bya spine (122) that follows the axis of the ellipsoid matrix. A series ofribs (123) protrude radially from the spine. Coplanar ribs (123) aredepicted here as three in number, but could be more; ideally, no lessthan three would occupy a single transverse plane of the ellipsoid.Alternatively, the ribs (123) could stack in a spiral. The tip (124) ofeach rib would ideally protrude just past the surface of the matrix(120) in the nondegraded state. A cross-sectional view of the framework(121) is shown in FIG. 42B. As engineered, the framework (121) shoulddegrade more slowly than the matrix (120) revealing more and more of theribs (123). Thus, as the matrix resorbs and grows smaller, the retentiondevice remains intact. The tips (124) of the ribs remain in contact withthe sinus mucosa, but with considerably less surface area of contactthan the matrix alone, thus decreasing the mucociliary clearance actionby orders of magnitude. Once the matrix (120) is completely degraded,some framework (121) elements would be expected to remain for somefinite interval before degrading completely themselves.

FIG. 43A shows the second embodiment of the drug delivery device of thepresent invention. FIG. 43B shows a cross-sectional view. The drugdelivery device comprises a matrix (130) and an embedded degradableframework (131) design. In addition, this framework (131) is alsoanchored by a coaxial spine (132). Distinct from the embodiment depictedin FIG. 42A, however, is an expansile “umbrella” of ribs (133) alsoattached radially to the spine (132); here the attachment is outside thematrix (130) at one apex. The umbrella (134) is collapsed around thesurface of the matrix (130) within the receptacle (see FIGS. 38 and 39)of the insertion device. As shown in FIG. 43C (and cross-sectional viewFIG. 43D), the umbrella (134) then expands upon extrusion into thesinus. The retention and degradation properties of the drug deliverydevice are similar to those outlined in the discussion of the embodimentillustrated in FIG. 42A.

FIG. 44A shows the third embodiment of the drug delivery device of thepresent invention. FIG. 44B shows a cross-sectional view. The drugdelivery device shares with the earlier embodiments the matrix (140) andembedded degradable framework (141) design. It, too, can be anchored bya coaxial spine (142), though this is not strictly necessary. Here, thematrix is surrounded at its surface by a cage (143) that is embedded inbut projects just above the surface of the matrix (140) to enhance itsretention properties at the outset. As the matrix (140) degrades, itremains within the confines of the cage (143) until the matrix (140)fragments become small enough to extrude through the openings in thecage (143). Other retention and degradation properties are similar tothose outlined above.

Benefits of the Present Invention

Unique to the present invention, the combination of the minimallyinvasive anterior keyhole approach, the described guide-free drugplacement devices, and the absence of any retained reservoir allowsurgeons to consider several new uses for targeted therapeutic agents:

-   -   1. Surgeons will have a reasonable intermediate option between        pure oral medical therapy and even minimally invasive ostial        dilation procedures. A patient that failed several standard oral        medical regimens might reasonably opt to have in-office        placement of pharmaceuticals via the described approach. Such an        option may have a substantial chance of succeeding where oral        therapy failed and without even resorting to minimally invasive        surgical options of the prior art or of the present invention.    -   2. As an adjunct to minimally invasive or routine sinus surgery        of the prior art or of the present invention, in lieu of oral or        other topical agents that are generally given in the context of        sinus surgery.    -   3. The treatment of postoperative patients regardless of the        surgical method used to treat them. This flexibility is quite        valuable in that many postoperative patients will need further        medical therapy on a repeated basis over the long term. For such        patients, the major advantage of the method of the present        invention is that it allows simple in-office treatment of the        problem with a lower anticipated side-effect profile than        typical for oral agents, and with a vehicle that mimics the cost        structure and simplicity of administration of those oral agents,        unlike any option available in the prior art.

1. A method of treating a congested anterior ethmoid sinus comprising: i. dilating the hiatus semilunaris superior; ii. making a perforation in the anterior wall of the ethmoid bulla; iii. advancing a dilator through the perforation until it reaches the ethmoid bulla ostium; and iv. dilating the ethmoid bulla ostium.
 2. A method of treating a congested anterior ethmoid sinus comprising: i. dilating the hiatus semilunaris superior; ii. making a perforation in the anterior wall of the ethmoid bulla; iii. dilating the perforation; iv. advancing a dilator through the perforation until it reaches the ethmoid bulla ostium; and v. dilating the ethmoid bulla ostium.
 3. The method of claims 1, wherein the dilator is a guide-free dilator.
 4. The method of claim 1, further comprising retracting the middle turbinate prior to dilating the hiatus semilunaris superior.
 5. A method of treating a congested anterior ethmoid sinus comprising: i. retracting the middle turbinate; ii. dilating the hiatus semilunaris superior; iii. making a perforation in the anterior wall of the ethmoid bulla; iv. advancing a dilator through the perforation until it reaches the ethmoid bulla ostium; and v. dilating the ethmoid bulla ostium.
 6. The method of claims 5, wherein the dilator is a guide-free dilator.
 7. The method of claim 6, wherein the guide-free dilator contains a balloon.
 8. A probe capable of making a perforation in the wall of the ethmoid bulla comprising: i. a handle having a top portion and a bottom portion; ii. an upper shaft mounted on the top portion of said handle; iii. a perforator tip with a stop collar, said perforator tip mounted on the upper shaft, wherein the perforator tip has a sharp end for making a perforation in the wall of the ethmoid bulla; and iv. optionally, a lower shaft mounted on the bottom portion of said handle.
 9. The probe of claim 8, further comprising a dilator tip mounted on the lower shaft for dilating the perforation made in the wall of the ethmoid bulla.
 10. The probe of claim 9, wherein the dilator tip is bluntly tapered at its distal end and rounded at its proximal end.
 11. A method of treating a congested anterior ethmoid sinus comprising: i. advancing an instrument into the antrum of the ethmoid bulla; ii. engaging the ethmoid bulla ostium with the instrument; stretching the ethmoid bulla medially and anteriorly; iv. advancing a dilator into the antrum of the ethmoid bulla; and v. dilating the ethmoid bulla ostium.
 12. The method of claim 11, further comprising dilating the hiatus semilunaris superior.
 13. The method of claims 11, further comprising retracting the middle turbinate prior to advancing the instrument into the antrum of the ethmoid bulla.
 14. A medial ethmoid probe comprising: i. a handle having a top portion and a bottom portion; and ii. a shaft having a proximal segment and a distal segment, said proximal segment comprising a rigid material mounted on the top portion and the bottom portion of the handle and said distal segment comprising a semirigid material with a curved tip to engage an ostium in the ethmoid bulla, wherein the distal segment of the shaft curves to an angle ranging from about 30 degrees to about 60 degrees.
 15. The medial ethmoid probe of claim 14, wherein the distal segment is wedge-shaped.
 16. The medial ethmoid probe of claim 14, wherein the length of the distal segment ranges from about 0.7 cm to about 1.5 cm.
 17. The medial ethmoid probe of claim 14, wherein the length of the distal segment is about 1.2 cm.
 18. The medial ethmoid probe of claim 14, wherein the angle at the distal segment of the shaft at the bottom portion of the handle and at the top portion of the handle are identical.
 19. The medial ethmoid probe of claim 14, wherein the angle at the distal segment of the shaft at the bottom portion of the handle and at the top portion of the handle are different.
 20. The medial ethmoid probe of claim 14, wherein the angle at the distal segment of the shaft at the bottom portion is about 30 degrees and the angle of the distal segment of the shaft at the top portion of the handle is about 60 degrees.
 21. The medial ethmoid probe of claims 14, wherein the distal segment is comprised of a material selected from the group consisting of silicone rubber, polyurethane, polyethylene terephthalate, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, and polytetrafluoroethylene.
 22. A method of delivering a drug to a congested ethmoid sinus comprising: i. advancing an instrument into the antrum of the ethmoid bulla; ii. engaging the ethmoid bulla ostium with the instrument; iii. stretching the ethmoid bulla medially and anteriorly; iv. introducing a drug insertion instrument between the middle turbinate and the ethmoid bulla; v. advancing the drug delivery instrument through the ethmoid bulla ostium; and vi. releasing a drug or drug delivery device into the ethmoid bulla.
 23. The method of claim 22, wherein the drug delivery device provides for controlled release of the drug. 